Clinical Trials Units
The BHF CRC have established a list of accredited clinical trial units (CTUs) who have expertise in cardiovascular trials and have agreed to partner with us to promote the quantity and quality of research in this field.
These first-rank units have all achieved recognition by the UKCRC and NIHR. We are confident that prospective cardiovascular researchers will be able to identify an ideal trials unit partner from this group.
If you work with or know of a CTU that is not listed below, please do get in touch via our email address enquiries@bhfcrc.org for further information on how to collaborate with the BHF CRC.
CTU Consultancy Packages
The BHF CRC offer UK researchers the opportunity to consult with a leading CTU to address questions in, and refine the design of, research projects. Eligible projects must be towards the later stages of development (rather than conceptual) and be of sufficient scale or merit that they will attract the support of one of our established Research Groups. Smaller scale studies or those in early-stage development are not applicable for this initiative and should be directed towards the NIHR Research Design Service. Researchers can choose the CTU they would like to work with from the list of our partnered CTUs above.
We hope that this initiative will allow researchers to:
- Establish a relationship with a premier CTU, best suited to their proposed study
- Promote CTU involvement at the appropriate stage in study design
- Provide answers to key questions in methodology, statistics or practical design to further study development.
How to apply
Complete the application form and send this along with your trial protocol to enquiries@bhfcrc.org
Process
Support packages will be available from May 2021 and continue until the allocated budget for the project has been spent.
Barts Cardiovascular CTU
Areas of Research
- Pre Clinical Testing
- Phase 2 and 3
- Long-term surveillance/population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies involving recruitment outside the UK
Sponsorship
We prefer not to take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Our mission is to support cardiovascular research by delivering excellence in the design, conduct, and dissemination of clinical trials with the aim of improving patient care.
We support clinical studies focused on the broad area of cardiovascular research and across the Cardiac and vascular sub-specialites
.
Our unit provides trial expertise, and support and oversight. The Barts CVCTU consists of a dedicated core team who manage the day-to day running of clinical trials, with CVCTU trial portfolio adoption coordinated by the Scientific and Resource Committees, and a Steering Committee to oversee resources, development and strategic direction. Specifically we provide trial oversight and management, statistical support, database creation and management, randomisation and blinding support, quality control and assurance.
We have experience of delivering phase 2 and 3 studies, both non-CTIMP and CTIMP for nutritional, drug or device interventions.
- PERSONAL COVID-BP- ClinicalTrials.gov Identifier: NCT04559074
- Prophesy- ClinicalTrials.gov Identifier: NCT03715348
- NITRATE-TOD- ClinicalTrials.gov Identifier: NCT03088514
- BYPASS-CTCA- ClinicalTrials.gov Identifier: NCT03736018
Address: William Harvey Research Institute, Barts & The London School of Medicine Charterhouse Square, London, EC1M 6BQ
Telephone number: +44(0) 20 7882 5668
Email address: CVCTU@qmul.ac.uk
Website: https://www.qmul.ac.uk/whri/clinical-activities/cvctu/
Birmingham Clinical Trials Unit
Areas of Research
- Phase 2, 3 and 4
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies involving recruitment outside the UK
Sponsorship
We (or our parent university/organisation) prefer to act as the sponsor
Particular areas of interest or experience in cardiovascular trial design and delivery
BCTU is a UKCRC-registered, large clinical trials unit with a specific focus on late-phase trials. In collaborating with BCTU, Investigators are supported to work up their ideas or pilot studies into full-scale projects. BCTU offers advice on trial design and methodology, and advice and help with grant applications. Support is available from an expert multi-disciplinary team on the most appropriate trial designs, methodology and trial management.
Within BCTU’s broad research portfolio are a number of cardiovascular trials which include clinical trials of investigational medicinal products (CTIMPs), surgical trials and those focusing on treatment in the paediatric population. They range from small, single centre studies, to multi-centre national studies with international collaborations. A major focus of the cardiology trials managed by BCTU, is atrial fibrillation (IMPRESS-AF and RATE AF), in particular management of the condition and impact on quality of life. Other BCTU-managed cardiovascular trials include investigating the benefits of diuretics on left ventricular mass in patients with renal disease (SPIRO-CKD), investigating treatment options for isolated or incidental sub-segmental pulmonary embolism (STOP-APE) and a comparison of del Nido and St Thomas cardioplegia solutions in children undergoing cardiac surgery (DESTINY). Additionally, BCTU has considerable expertise in the delivery of surgical trials, amongst which are the peripheral vascular disease-focussed, BASIL-2 and 3 trials.
The University of Birmingham (UoB) is the preferred sponsor for trials that are managed by BCTU, however collaborations with Chief Investigators (CIs) employed by other organisations are welcomed.
- DESTINY – Del Nido versus St. Thomas’ blood cardioplegia: a multi-centre randomised controlled trial in children undergoing cardiac surgery (in set-up)
- RATE AF – RAte control Therapy Evaluation in permanent Atrial Fibrillation. Evaluating different rate control therapies in permanent atrial fibrillation: A prospective, randomised, open-label, blinded endpoint study comparing digoxin ans beta-blockers as initial rate control therapy (NCT02391337)
- SPIRO-CKD – A randomised, multicentre, open-label, blinded endpoint trial to compare the effects of Spironolactone to Chlortalidone on left ventricular mass and arterial stiffness in stage 2 and stage 3 chronic kidney disease (ISRCTN 94696478)
- BASIL-2 Bypass vs. Angioplasty in Severe Ischaemia of the Leg-2 (ISRCTN 27728689)
- IMPRESS-AF – a double-blinded randomised placebo-controlled trial of 2-year treatment with an aldosterone antagonist, spironolactone (25mg once daily) vs placebo in 250 patients with symptomatic chronic atrial fibrillation and preserved left ventricular contractility (NCT02673463)
Address: Institute of Applied Health Research, Public Health Building, College of Medical and Dental Sciences, University of Birmingham, Birmingham, B15 2TT
Telephone number: 0121 415 9100
Email address: bctu@contacts.bham.ac.uk
Website: https://www.birmingham.ac.uk/research/bctu/index.aspx
Brighton and Sussex Clinical Trials Unit
Areas of Research
- Phases 2,3 and 4
- Long-term surveillance/population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies involving recruitment outside the UK
Sponsorship
We cannot take the sponsorship role
Particular areas of interest or experience in cardiovascular trial design and delivery
BSCTU is a relatively new CTU and we are developing collaborations with the Cardiology research team here in Brighton. We are currently managing one clinical trial in cardiology. We have a strong track record of working on a range of studies from CTIMPs and other Interventional studies across a range of health disciplines and designs ranging from Randomised Controlled Trials, cluster randomised and step wedge designs as well as using novel technologies for the delivery of studies. We are used to handling large data sets.
Address: Watson Building, Room 110, Village Way, Falmer, Brighton BN1 9PH
Telephone number: 01273 641469
Email address: 01273 641469
Website: www.bsms.ac.uk/ctu
Cambridge Clinical Trials Unit
Areas of Research
- Phase 1, 2, and 4
- Long-term surveillance/population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We prefer to act as the sponsor
Particular areas of interest or experience in cardiovascular trial design and delivery
The Cambridge CTU runs clinical trials of all phases and also physiological and epidemiological studies. We have a particular interest in early phase trials / experimental medicine studies and welcome studies done in partnership with industry. There are strong links with clinical pharmacology to support design and execution of first-in-human studies, and a wide range of techniques are available on site to help with early proof-of-concept / mechanism. We have established links with the MRC biostatistic Unit (on site) to help with innovative clinical trial design and are currently running a number of adaptive clinical trials. We have also worked in partnership with the NIHR BioResource to run a number of physiological profiling studies based on “recall by genotype”. We welcome approaches from investigators outside the campus and industry.
- Phase 2 Losmapimod in Chronic Obstructive Pulmonary Disease Patients Stratified by Fibrinogen. (EVOLUTION)
https://clinicaltrials.gov/ct2/show/NCT01541852 - Expt Medicine Evaluating the Effect of Standard-of-care Erythropoiesis-stimulating Agents on Forearm Blood Flow in Nondialysis-dependent Subjects With Anaemia Associated With Chronic Kidney Disease. (OPERA-CKD) https://clinicaltrials.gov/ct2/show/NCT02987465
Address: Box 401, Level 6, Coton House, Cambridge University Hospitals NHS Foundation
Telephone number: 01223 596474
Email address: CCTU@addenbrookes.nhs.uk
Website: https://cctu.org.uk/, https://www.camcovidtrials.net/
Comprehensive Clinical Trials Unit at UCL
Areas of Research
- Phase 1, 2, 3 and 4
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Members of CCTU have extensive cardiovascular research experience, and we are currently engaged with an active cardiovascular portfolio. We have experience in pharmaceuticals, class III devices, surgical interventions. CCTU is a multidisciplinary trials unit which includes operations, statistics, IT specialists, health economists and quality assurance and regulatory experts. We are part of the UCL Institute of Clinical Trials and Methodology which is the one of the biggest groupings of trial methodologists in the world.
OPTIMAS is a large, prospective, partially blinded randomised controlled trial of early (within ≤4 days [96hrs]) or standard (between day 7 and day 14 after stroke onset) initiation of anticoagulation after stroke in patients with atrial fibrillation (AF), using any licensed dose of a direct oral anticoagulant (DOAC). The trial will use a non-inferiority gatekeeper approach to test for non-inferiority of early anticoagulation followed by a test for superiority, if non-inferiority is established.
https://clinicaltrials.gov/ct2/show/NCT03759938
Address: 90 High Holborn 2nd Floor London WC1V 6LJ UK
Telephone number: +44 (0) 20 7907 4669
Email address: cctu-enquiries@ucl.ac.uk
Website: https://www.ucl.ac.uk/comprehensive-clinical-trials-unit/
Edinburgh Clinical Trials Unit
Areas of Research
- Phase 1, 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We (or our parent university / organisation) prefer to act as the sponsor
Particular areas of interest or experience in cardiovascular trial design and delivery
Founded in 2006, the Edinburgh Clinical Trials Unit (ECTU), led by Professor John Norrie, is a UK-CRC registered unit based within the Usher Institute of Edinburgh University. The unit provides the infrastructure and expertise necessary to design, plan and deliver clinical trials and works closely with the local sponsor, the Academic and Clinical Central Office for Research and Development (ACCORD). Our dedicated Research Development Team support investigators to translate their research ideas into high-quality grant applications.
ECTU’s research portfolio contains many cardiovascular trials including CTIMPs, randomised clinical trials, meta-analysis and observational studies. We select our trials in line with our strategy to positively impact human health challenges and synergise with the research strengths of the University that include experimental/translational medicine, imaging and data science.
- SCOT-HEART2 (NCT03920176)
https://clinicaltrials.gov/ct2/show/NCT03920176?term=NCT03920176&draw=2&rank=1 - RESTART (ISRCTN71907627)
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30840-2/fulltext - DIAMOND
https://www.sciencedirect.com/science/article/pii/S1936878X19305571?via%3Dihub - SCOTHEART
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2815%2960291-4/abstract - HighSTEACS
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)31923-8/fulltext
Address: Usher Institute, University of Edinburgh, NINE Edinburgh BioQuarter, 9 Little France Road, Edinburgh, EH16 4UX
Telephone number: 0131 651 9901
Email address: ECTU-new.proposals@ed.ac.uk
Website: https://www.ed.ac.uk/usher/edinburgh-clinical-trials
Glasgow Clinical Trials Unit
Areas of Research
- Phase 1, 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
The Robertson Centre for Biostatistics (RCB) has a long (since 1988) and strong interest in cardiovascular & renal medicine, diabetes, neurosciences and, more recently, rehabilitation. The RCB together with the Research and Innovation (R&I) Department of Greater Glasgow and Clyde Health NHS Board and the Population Health Research Facility of the MRC/CSO Social and Public Health Sciences Unit, forms the Glasgow Clinical Trials Unit.
Current Director: Professor John Cleland
Previous Director: Professor Ian Ford
Lead Biostatisticians: Professor Alex McConnachie and Michele Robertson
Director R&I for NHS: Professor Julie Brittenden
Population Health Research: Professor Rod Taylor
We have led or contributed to many landmark trials in cardiovascular medicine including: WOSCOPS (pravastatin), PROSPER (pravastatin), IONA (nicorandil), CAPRICORN (carvedilol), BEAUTifUL (ivabradine), SHIFT (ivabradine), EchoCRT (CRT-D v. ICD), PATHWAY (hypertension), TRUST (thyroid hormone), DiRECT (weight loss in T2DM), PIVOTAL (IV iron), T-TIME (alteplase) and FAST (allopurinol v. febuxostat).
We provide a comprehensive service to support clinical trials including:-
- Research advisory services, including efficient trial design, endpoints, sample size & statistical analysis, implementation (including all the services mentioned below) and regulatory requirements.
- Personal, patient and public involvement panel support
- Project management
- Electronic case report forms
- Pharmacy clinical trials service
- Randomisation service
- Data management
- Data linkage to national electronic datasets to capture hospitalisations and deaths
- Site monitoring (for trials sponsored by Glasgow)
- Pharmacovigilance
- Statistical support for investigators and independent data monitoring committees
- Statistical analysis for reports and publications
- WOSCOPS (Commercial Funding)
https://www.nejm.org/doi/full/10.1056/NEJM199511163332001
https://www.nejm.org/doi/full/10.1056/NEJMoa065994 - BEAUTifUL & SHIFT (Commercial Funding https://www.nejm.org/doi/full/10.1056/NEJMoa1406430
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)61198-1/fulltext - Echo-CRT (Commercial Funding) https://www.nejm.org/doi/full/10.1056/NEJMoa1306687
- PIVOTAL (Kidney Research UK with Commercial Support)
https://www.nejm.org/doi/full/10.1056/NEJMoa1810742 - IRONMAN (BHF with Commercial Support)
https://clinicaltrials.gov/ct2/show/NCT02642562, www.ironmanstudy.co.uk
Address: University of Glasgow, University Avenue, Glasgow G12 8QQ
Telephone number: 0141 330 4744
Email address: contactus@glasgowctu.org
Website: https://www.glasgowctu.org/Home/, https://www.gla.ac.uk/researchinstitutes/healthwellbeing/research/robertsoncentreforbiostatistics/, https://www.nhsggc.org.uk/about-us/professional-support-sites/research-innovation/
Imperial Clinical Trials Unit
Areas of Research
- Phase 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Several members of ICTU staff have played major roles in various aspects of the delivery of several late-phase cardiovascular outcomes trials, including ASCOT, ADVANCE, UMPIRE, CREOLE, LEADER, EXSCEL, CLEAR Harmony, ORION 9,10,11, BETonMACE, STRENGTH, SCORED.
Particular expertise lies in translating critical research questions into an optimal design and in the logistical aspects of conducting large randomised trials involving multi-centre and multi-national collaborations. We have extensive experience of serving on DSMBs, end-point committees and steering committees and as global leads which have led to the approvals of novel therapies globally. Leading and conducting large scale registries have helped inform gaps in implementation prioritising and informing future guidelines.
- AARDVARK: Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK. https://clinicaltrials.gov/ct2/show/NCT01118520
- CREOLE: Comparison of Three Combination Therapies in Lowering Blood Pressure in Black Africans. https://clinicaltrials.gov/ct2/show/NCT02742467
- Da Vinci: EU-Wide Cross-Sectional Observational Study of Lipid-Modifying Therapy Use in Secondary and Primary Care. http://www.encepp.eu/encepp/viewResource.htm?id=31479
- ORION 11: Inclisiran for Subjects With ASCVD or ASCVD-Risk Equivalents and Elevated Low-density Lipoprotein Cholesterol. https://clinicaltrials.gov/ct2/show/NCT03400800
- BETonMACE: Effect of RVX000222 on Time to Major Adverse Cardiovascular Events in High-Risk T2DM Subjects With CAD. https://clinicaltrials.gov/ct2/show/NCT02586155
Address: Imperial College London, 1st Floor, Stadium House, 68 Wood Lane, London W12 7RH
Email address: ictustats@imperial.ac.uk
Website: https://www.imperial.ac.uk/clinical-trials-unit/collaborations/
Lancashire Clinical Trials Unit
Areas of Research
- Phase 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We prefer not to take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Lancashire Clinical Trials Unit (CTU) has a well-established track record in co-ordinating multi-centre trials and large complex interventional studies. We offer a full but bespoke service for all trial activities from conception, grant application and trial design including initiation, conduct, monitoring, analysis, reporting, dissemination including publication in peer-reviewed journals. We have led on study design, developing protocols, ethical and regulatory submissions (including producing Consent and Patient Information Sheets, Trial advertising materials, and developing and validating case report forms (CRFs). We develop monitoring plans (both centralised monitoring and site monitoring) using a risk-based approach which is informed by Project Risk Assessments.
Our cardiovascular portfolio includes large multi-site trials (e.g. HeadPoST and CONVINCE), trials with large sample sizes (e.g. HeadPoST (11096), CONVINCE (2623), ICONSII (1200)) and large observational studies (STROLLERS (3240)). We provide all CTU functions (trial management (TM), data management (DM), information systems (IS), statistics (ST) and Quality Assurance and Training (QA&T).
Our interests lie in: Stroke assessment and management; Psychological adjustment; Post-cardiovascular event health, including anxiety, depression, continence and swallowing; Functional recovery including dose finding for therapies to aid functional recovery; Emergency pathways; User involvement; and Needs assessment.
- Head Position in Stroke Trial (HeadPoST 41 UK sites, 5600 UK participants enrolled) https://clinicaltrials.gov/ct2/show/NCT02162017
- Confirming the Mechanism of Motivational Interviewing Therapy after Stroke (COMMITS)
https://www.uclan.ac.uk/research/activity/commits - COlchicine for preventioN of Vascular Inflammation in Non-Cardioembolic strokE (CONVINCE) (UK arm 60+sites) https://www.uclan.ac.uk/research/activity/convince
- IMPROVIng StrokE care India (IMPROVISE) https://uclanglobalhealth.co.uk/
- STROke, Life and LeisurE Research Survey (STROLLERS) https://www.uclan.ac.uk/research/activity/stroke-life-and-leisure-research-survey-strollers
Address: Brook Building, University of Central Lancashire, Preston, PR1 7QR
Email address: lancashirectu@uclan.ac.uk
Website: https://www.uclan.ac.uk/research/activity/lancashire-clinical-trials-unit
Leeds Institute of Clinical Trials Research
Areas of Research
- Phase 2, 3 and 4
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
We are a leading UK academic clinical trials unit with a track-record in design, conduct and analysis of both early and late-phase high-quality academic clinical trials, influencing national and international clinical practice. Our research is conducted through the Clinical Trials Research Unit (CTRU) and our cardiovascular portfolio sits within the Surgical Interventions, Diagnostics and Devices (SIDD) Division. Our experience ranges from definitive, large-scale, international, randomised controlled trials to single-centre, earlier-phase research including feasibility and qualitative work; together with methodological research investigating real-world challenges of surgical and device evaluations.
Within our cardiovascular portfolio, the focus on surgical interventions, surgical devices and diagnostic devices (including algorithmic interventions), allows us to specialise in innovative and efficient trial design and delivery in these areas. Specifically, our research to date has included a series of studies aiming to identify optimal methods of imaging for accurate diagnosis of cardiovascular disease, risk stratification in treatment approaches, utilising real world evidence and international meta-analysis.
- The UKGRIS trial (in analysis)
Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK. http://dx.doi.org/10.1136/bmjopen-2019-032165 - The CE MARC Trial (published)
Cardiovascular magnetic resonance and single-photon emission computed tomography for diagnosis of coronary heart disease (CE-MARC): a prospective trial. https://doi.org/10.1016/S0140-6736(11)61335-4 - The CE MARC 2 Trial (published)
Effect of Care Guided by Cardiovascular Magnetic Resonance, Myocardial Perfusion Scintigraphy, or NICE Guidelines on Subsequent Unnecessary Angiography Rates: The CE-MARC 2 Randomized Clinical Trial. https://doi.org/10.1001/jama.2016.12680 - The OPT-C study – Optimising Pacemaker Therapy for Contractility
Personalized Rate-Response Programming Improves Exercise Tolerance After 6 Months in People With Cardiac Implantable Electronic Devices and Heart Failure: A Phase II Study. https://doi.org/10.1161/CIRCULATIONAHA.119.045066 - The Liberates trial (in analysis)
A randomised controlled trial of flash glucose monitoring for optimisation of glycaemia in individuals with type 2 diabetes and recent myocardial infarction. https://doi.org/10.1177/1479164120957934
Address: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT
Email address: LICTRComms@leeds.ac.uk
Websites: https://medicinehealth.leeds.ac.uk/leeds-institute-clinical-trials-research, https://medicinehealth.leeds.ac.uk/faculty-/dir-record/research-groups/899/surgical-interventions-diagnostics-and-devices
Leicester Clinical Trials Unit
Areas of Research
- Phase 1, 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
We have experience in planning and conducting a range of cardiovascular trials from single site early phase trials looking at safety and efficacy to large multi-site late phase trials looking at effectiveness. Trial settings include primary and secondary care, recruiting throughout the UK and also more recently to include international collaboration. With large trials we focus on ensuring the design is pragmatic and use routine data collection where possible. A number of our trials also include sub studies providing further significant outputs. Our portfolio includes major cardiovascular studies in management of myocardial infarction, treatment pathway of aortic stenosis and outcomes of cardiac surgery.
In addition to the clinical cardiovascular expertise of our director, we also have statistical and trial management expertise in areas including cluster trials, umbrella trials and platform trials.
- EASY-AS : A Randomised Controlled Trial of Early valve replacement in severe ASYmptomatic Aortic Stenosis.
ClinicalTrials.gov link: https://www.clinicaltrials.gov/ct2/show/NCT04204915 - PHAST: Peripheral arterial disease, High blood pressure and Aneurysm Screening Trial (PHAST) – An evaluation of the acceptability, effectiveness and cost effectiveness of screening for peripheral arterial disease and high blood pressure at the same time as abdominal aortic aneurysm. This study is funded by the NIHR and has been designed with the help of men who have been through the AAA screening process.
The PHAST Study is a multicentre, UK-based study, with the aim of finding out whether screening for peripheral arterial disease (PAD) and high blood pressure (BP) at the same time as screening for abdominal aortic aneurysms (AAA) improves cardiovascular health.
Currently, 30% to 40% of people over the age of 65 have PAD and/or high BP. At least one-third of these people don’t know that they have these conditions. People who do have these conditions are at high risk of heart attacks, strokes and other cardiovascular problems.
This study will identify the best devices for testing PAD and BP and then take these forward into screening. Where applicable, these tests will be combined with the AAA screening programme that is already in place nationally. We will be asking both researchers and participants about their experience of the additional screening tests.
The most appropriate device or devices will be determined via a systematic review and assessments by experts in this field. The study will then initially be conducted as a mixed methods feasibility study, in which approximately 3000 men and 3000 women will be asked to undergo PAD and BP screening. For men this will be alongside the standard AAA screening pathway. As women are not invited for AAA screening due to low incidence, the BP and PAD assessments will not form part of any other screening programme. Suitable participants will be asked if they would like to contribute to qualitative and follow up sub-studies.
The feasibility will inform the final part of the PHAST study: a cluster randomised crossover trial which will randomised PAD+BP+AAA screening to AAA screening only. Screening units will recruit for two years and we hope to recruit 260,640 participants. Participants will be followed up for three years for cardiac and limb events. - RAPID NSTEMI: A randomised controlled trial of very early angiography +/- intervention versus standard of care on outcomes in patients with non ST-elevation myocardial infarction
Very Early Versus Delayed Angiography +/- Intervention on Outcomes in Patients With NSTEMI - REVAKI-2: Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial
ISRCTN – ISRCTN18386427: The effect of sildenafil (REVATIO®) on post cardiac surgery acute kidney injury - REVAKI 1: A Phase I Study to Determine the Pharmacokinetic Profile, Safety and Tolerability of Sildenafil (REVATIO®) in Cardiac Surgery: The REVAKI-1 Study. ClinicalTrials.gov (NCT02136329). https://clinicaltrials.gov/ct2/show/NCT02136329
Address: Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Maurice Shock Building, University Road, Leicester LE1 7RH
Telephone number: +44 (0)116 229 7246
Email address: ctu@leicester.ac.uk
Websites: https://le.ac.uk/lctu, https://le.ac.uk/lctu/trials, https://le.ac.uk/lctu/publications
Liverpool Clinical Trials Centre
Areas of Research
- Phase 1, 2, 3 and 4
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
The Liverpool Clinical Trials Centre is a leading UK clinical trials unit and methodological research group. We bring together a wealth of expertise built on the experience of the Liverpool Trials Collaborative which has held full registration status with the UK Clinical Research Collaboration CTU network since its establishment in 2007. We are based in the Faculty of Health and Life Sciences at the University of Liverpool, a member of the Liverpool Health Partners.
We work with the NHS and commercial partners, patients and the public to contribute to the identification and evaluation of new and innovative treatments and devices. We have particular expertise in personalised medicine, surgical interventions, and re-purposing of and establishing evidence for existing treatments used within the NHS. In partnership with other trials methodologists we contribute to the advancement of methods to improve the design and delivery of clinical trials.
- PIROUETTE – https://doi.org/10.1186/ISRCTN91621241
- TEMPEST – https://clinicaltrials.gov/ct2/show/NCT04706429
- UK-COMPASS – https://fundingawards.nihr.ac.uk/award/15/153/02
- AFFIRMO – https://cordis.europa.eu/project/id/899871
- HEAL-COVID – https://clinicaltrials.gov/ct2/show/NCT04801940, https://heal-covid.net/
Address: c/o, Room F106/Admin Office, Block F Waterhouse Building 1-5 Brownlow Street, Liverpool, L69 3GL
Telephone number: 0151 794 9752
Email address: lctc@liverpool.ac.uk
Website: lctc.org.uk
London School of Hygiene & Tropical Medicine Clinical Trials Unit
Areas of Research
- Phase 3
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Studies involving recruitment outside the UK
Sponsorship
We prefer not to take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
The LSHTM CTU cardiovascular team specialises in the design, conduct and analysis of pragmatic multicentre clinical trials, often with simple interventions or treatment strategies.
We have developed strong links with many of the top cardiovascular hospitals in the UK over the past 30 years, beginning with the BHF-funded RITA, RITA-2 and RITA-3 trials. Through these collaborations with sites we aim to develop efficient trials which can be conducted with minimal complexity while delivering important results.
We are also strongly committed to Patient and Public Involvement (PPI), and work in close collaboration with Cardiovascular PPI representatives at each stage of research from design to dissemination of results.
As well as trial design, conduct and management we have world renowned expertise in statistical methodology, analysis and interpretation of large scale cardiovascular trials. This includes development of novel statistical methods (such as the Win Ratio) and publication of educational articles specifically in the design and analysis of cardiovascular trials.
We also support the statistical design, data monitoring, analysis and publication for a larger set of major industry sponsored international cardiovascular trials.
We have direct experience in delivering emergency research in the NHS, for example in advance of primary percutaneous coronary intervention (PCI) (ERIC-PPCI) or in cardiac arrest (ARREST), or within primary care (StatinWISE). We have worked on trials in coronary artery bypass surgery (ERICCA, RITA, RITA-2, Tight K), remote ischaemic pre-conditioning (ERICCA, ERIC-PPCI, REPAIR), PCI (RITA, RITA-2, RITA-3, REVIVED, ERIC-PPCI, CHIP-BCIS3) and transcatheter aortic valve implantation (BHF PROTECT-TAVI).
- ERIC-PPCI – https://clinicaltrials.gov/ct2/show/NCT02342522
- REVIVED – https://clinicaltrials.gov/ct2/show/NCT01920048
- ERICCA – https://clinicaltrials.gov/ct2/show/NCT01247545
- BHF PROTECT-TAVI – http://www.isrctn.com/ISRCTN16665769
- ARREST – http://www.isrctn.com/ISRCTN96585404
Address: Keppel Street, London, WC1E 6HT
Telephone number: +44 (0)20 7299 4684
Email address: ctu@lshtm.ac.uk
Website: https://ctu.lshtm.ac.uk/
Newcastle Clinical Trials Unit
Areas of Research
- Phase 1, 2, 3 and 4
- Long-term surveillance/population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We cannot take the sponsorship role
Particular areas of interest or experience in cardiovascular trial design and delivery
We have a substantial track-record in the development and delivery of robust multi-centre surgical and interventional cardiovascular clinical trials; in recent years we have collaborated on 12 trials including phase III trials in minimally invasive cardiac surgery, pilot trials in pre-habilitation, early phase CTIMPS and Phase III/IV trials, as well as reaching across to other specialties, including to oncology in the treatment of cardiotoxicity. We have a track record in device trials across other specialties that is transferable here.
We have recognised expertise and capacity in adaptive trial design (including leading an NIHR-funded project to develop national guidance for resource in adaptive trials), in CTIMPs and in surgical trials, focusing on the most appropriate design for each research question.
Our team, which includes methodologists, biostatisticians, health economists, works with investigators to develop high quality applications for funding and, ultimately, delivers a portfolio of practice-changing trials for patient benefit.
- Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).
https://clinicaltrials.gov/ct2/show/NCT04514315?term=mini+mitral&cond=cardiac+surgery&draw=2&rank=1 - Preventing cardiac damage in patients treated for breast cancer: a phase 3 Randomised, Open label, blinded endpoint, superiority trial of enalapril to prevent Anthracycline-induced CardioToxicity (PROACT)
https://clinicaltrials.gov/ct2/show/NCT03265574?term=PROACT&draw=2&rank=5 - Telomerase ACTivator to reverse Immunosenescence in Acute Coronary Syndrome: a double-blind, phase II, pilot randomised controlled trial (TACTIC) https://doi.org/10.1186/ISRCTN16613292
- Is pre-habilitation feasible and effective in elderly patients undergoing cardiac surgery? (PrEPS) https://doi.org/10.1186/ISRCTN13860094
- The British Heart Foundation older patients with non-ST SEgmeNt elevatIOn myocaRdial infarction Randomized Interventional TreAtment Trial (SENIOR-RITA) https://clinicaltrials.gov/ct2/show/NCT03052036?term=SENIOR+RITA&cntry=GB&draw=2&rank=1
Address: Newcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE
Telephone number: (0191) 208 2522
Email address: nctu-enquiries@newcastle.ac.uk
Website: https://www.ncl.ac.uk/nctu/
Norwich Clinical Trials Unit
Areas of Research
- Phase 2 and 3
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
Sponsorship
We prefer not to take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
Norwich CTU has core competencies in statistics, health economics, process evaluation, data management, randomisation, trial project management and quality systems and holds full UK CRC registration. We have substantial experience in providing multidisciplinary methodological support to early career researchers, academic clinical fellows and first-time CIs, both regionally and nationally.
We have experience in the design and delivery of complex interventions, clinical trials of investigational medicinal products and medical device trials (including active implantable devices such as pacemakers).
Address: Norwich Clinical Trials Unit, University of East Anglia, Norwich. NR4 7TJ
Telephone number: 01603 591035
Email address: NorwichCTU@uea.ac.uk
Website: https://sites.uea.ac.uk/norwichctu/
Oxford Primary Care & Vaccine Collaborative Clinical Trials Unit
Areas of Research
- Phase 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies to support international regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Address: Nuffield Department of Primary Care Health Sciences, Gibson Building, 1st Floor, Radcliffe Observatory Quarter, Oxford. OX2 6GG
Telephone number: 01865 617855
Email address: primarycarectu@phc.ox.ac.uk
Website: https://www.phc.ox.ac.uk/phctrials
Tayside Clinical Trials Unit
Areas of Research
- Phase 2, 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
- Studies to support UK regulatory approval
- Studies involving recruitment outside the UK
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
TCTU has extensive experience of successful cardiovascular trial design and delivery. We routinely provide pre-award support, managing the preparation of research bids for large multicentre drug trials and intervention studies as well as smaller, single-site trials. Support begins in depth from early in the evolution of the research question through to novel and innovative trial delivery approaches, development of patient pathways, recruitment strategies, sample size calculation and budget preparation including liaising with academic collaborators and third-party providers. Patient and public engagement is central to our activity and built into every application.
Dedicated, funded post-award support is available in three main areas: trial management, data management and statistical analysis. TCTU may be responsible for all aspects of trial delivery, data quality, analysis and dissemination or provide standalone packages, e.g. GCP-compliant data management system, randomisation and drug management system, interim and final analysis. TCTU also provides training and mentoring to early-stage researchers and clinical teams.
TCTU is keen to underpin a multidisciplinary approach to cardiovascular research and associated co-morbidities, including the identification of novel biomarkers and innovative treatment approaches, especially where no effective therapies currently exist. While supporting CTIMPs and complex intervention studies, we are also interested in supporting community-based research and have experience of a range of cardiovascular endpoints and imaging techniques. We also support early-stage researchers as well as established research teams. TCTU trial managers have developed a broad spectrum of cardiovascular trial protocols and patient-facing documentation, and successful recruitment strategies from a wide range of patient pathways.
- ALPHA: Does allopurinol reduce right ventricular mass in lung disease associated with pulmonary hypertension
ISRCTN: 11081180 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7457596/ - VESUVIUS: Vascular effects of regular effects versus electronic cigarette use
CT.gov: NCT 02878421 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6928567/ - DAPA LVH: Does Dapaglifozin Regress Left Ventricular Hypertrophy In Patients With Type 2 Diabetes?
CT.gov: NCT 02956811 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5569551/ - ALTERED: Does Allopurinol Regress Left Ventricular Hypertrophy In End Stage Renal Disease
CT.gov: NCT 01951404 https://www.sciencedirect.com/science/article/pii/S2468024920316958?via%3Dihub - LACE: Perindopril and leucine to improve muscle function in older people
ISRCTN: 90094835 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5753568/
Address: TASC R&D Office, University of Dundee, Ninewells Hospital and Medical School, Residency Block Level 3, George Pirie Way, Dundee DD1 9SY
Telephone number: 01382 383581
Email address: tctu@dundee.ac.uk
Website: https://www.dundee.ac.uk/tctu/
York Trials Unit
Areas of Research
- Phase 3 and 4
- Long-term surveillance/ population/epidemiology studies
- Studies bidding to or supported by; charitable funding, NIHR funding, commercial funding, and other funding
- Clinical Trials of an Investigational Medical Product (CTIMP)
Sponsorship
We can take the sponsorship role but have flexibility
Particular areas of interest or experience in cardiovascular trial design and delivery
York Trials Unit has a strong reputation and expertise for doing large pragmatic trials of complex interventions. We have experience of numerous trial designs including: placebo controlled drug trials, open label drug studies, individually randomised pragmatic trials of complex interventions, cluster randomised trials, stepped wedge trials, factorial trials, patient preference trials, randomised consent designs and Trials within Cohorts (TWICS). We have approximately 100 staff and cover all the methodological areas needed for supporting large trials including: statistics, trial co-ordination/management, health economics, data management, Public and Patient Involvement and qualitative research. We are a UKCRC registered clinical trials unit and we are also one of the Royal College of Surgeons registered trials units. Clinically areas where we have supported trials include: surgery, rehabilitation and pre-habilitation, therapist interventions and placebo controlled drug trials. In cardiovascular treatments we have and are supporting trials in wound care (chronic and surgical wounds), cardiac rehabilitation, rapid access chest pain clinics, morphine for patients with chronic heart failure and oxygen for patients with heart failure. For these trials we have undertaken their design, supported their conduct (trial and data management) and undertaken the statistical, health economic and qualitative analysis. We have a close relationship with the Cardiovascular health research group in the Department, which houses the National Audit of Cardiac Rehabilitation (led by Doherty).
- Hicks, K, Cocks, K, Corbacho Martin, B, Elton, P, MacNab, A, Colecliffe, W & Furze, G 2014, ‘An intervention to reassure patients about test results in rapid access chest pain clinic: a pilot randomised controlled trial’, BMC Cardiovascular Disorders, vol. 14, 138. https://doi.org/10.1186/1471-2261-14-138 ISRCTN60618114
- Cockayne, S, Pattenden, J, Worthy, G, Richardson, G & Lewin, R 2014, ‘Nurse facilitated Self-management support for people with heart failure and their family carers (SEMAPHFOR): a randomised controlled trial’, International Journal of Nursing Studies, vol. 51, no. 9, pp. 1207-1213. https://doi.org/10.1016/j.ijnurstu.2014.01.010 ISRCTN84692046
- Clark AL, Johnson M, Fairhurst C, Torgerson D, Cockayne S, Rodgers S, Griffin S, Allgar V, Jones L, Nabb S, Harvey I, Squire I, Murphy J, Greenstone M. Does home oxygen therapy (HOT) in addition to standard care reduce disease severity and improve symptoms in people with chronic heart failure? A randomised trial of home oxygen therapy for patients with chronic heart failure. Health Technol Assess. 2015 Sep;19(75):1-120. doi: 10.3310/hta19750 ISRCTN60260702.
- Lewin RJ, Coulton S, Frizelle DJ, Kaye G, Cox H. A brief cognitive behavioural preimplantation and rehabilitation programme for patients receiving an implantable cardioverter-defibrillator improves physical health and reduces psychological morbidity and unplanned readmissions. Heart 2009;95:63–69. doi:10.1136/hrt.2007.129890 ISRCTN70212111
- Johnson MJ, Cockayne S, Currow DC, Bell K, Hicks K, Fairhurst C, Gabe R, Torgerson D, Jefferson L, Oxberry S, Ghosh J, Hogg KJ, Murphy J, Allgar V, Cleland JGF, Clark AL. Oral modified release morphine for breathlessness in chronic heart failure: a randomized placebo-controlled trial. ESC Heart Fail. 2019 Dec;6(6):1149-1160. doi: 10.1002/ehf2.12498. Epub 2019 Aug 6. ISRCTN41349358 .
Address: Department of Health Sciences, University of York, York, YO10 5DD
Telephone number: 01904 321726
Email address: sally.baker@york.ac.uk
Website: https://www.york.ac.uk/healthsciences/research/trials/