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