Serelaxin vs standard of care in acute heart failure patients
Research type
Research Study
Full title
A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients
IRAS ID
126102
Contact name
David Kuzan
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2013-002513-35
ISRCTN Number
NA
Clinicaltrials.gov Identifier
NA
Research summary
Acute Heart Failure(AHF)is a major public health problem and the most common cause of hospitalisation in the over 65s. This is projected to increase by 25% over the next 20 years. AHF is a rapid decline of the ability to breathe in a patient with heart failure, requiring emergency admission to hospital, and despite standard treatment death rates at 30 days, 1 year and 5 years remain high (10.4%, 22% and 42.3% respectively. Standard treatment has not changed in ten years and is focused on achieving short term symptom relief, and there is significant unmet need for AHF patients.
Relaxin (H2) is a naturally occurring peptide hormone associated with many maternal changes during pregnancy which allows blood vessels to relax and has other favourable effects. The study drug, Serelaxin, is identical in structure to Relaxin. This will be administered by infusion into a vein over 48 hours. Patients will be randomised to receive either the active drug and standard of care or standard of care alone. Patients will be randomised in a 2:1 ratio.
In the previous RELAX AHF trial a clinically and statistically significant 37% reduction in both cardiovascular and all cause mortality through Day 180 was seen. Data from this study is intended to evaluate the serelaxin effect in reducing in hospital worsening heart failure. It is expected that approximately 2700 patients will be recruited from around 300 centres in Europe, 100 of those patients coming from approx 10 UK centres.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
13/EM/0404
Date of REC Opinion
28 Nov 2013
REC opinion
Further Information Favourable Opinion