Effect of Serelaxin on cardiac troponin I release in patients with CHF
Research type
Research Study
Full title
A multicenter, randomized, double-blind, crossover placebo-controlled Phase II study to assess the effect of serelaxin versus placebo on high sensitivity cardiac troponin I (hs-cTnI) release in patients with chronic heart failure after exercise when used in addition to standard of care
IRAS ID
187947
Contact name
John G.F Cleland
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-002673-38
Duration of Study in the UK
1 years, 1 months, 16 days
Research summary
This is a multicenter, randomized, double-blind, crossover placebo-controlled Phase II trial. The main aim of the trial is to evaluate the effect of serelaxin compared to placebo on the release of biomarkers known as cardiac troponins when given in addition to standard medical treatment to patients with chronic heart failure. The effects of serelaxin on the release of cardiac troponins will be determined by measuring the levels of cardiac troponin for up to 5 hours after the start of an exercise testing session.
Serelaxin is being developed by Novartis, and this trial is sponsored by them. 125 patients will be included in this trial across 3 countries, UK, Switzerland and Germany.
Patients will be given an explanation of the study at a scheduled clinic visit, and then asked to sign a consent form if they agree to participate. The trial duration is 6 weeks and each patient will attend for 4 visits. The patient will be given either serelaxin or placebo at visit 2 and 3 in the clinic where the patients will stay for the whole day. The treatment will be administered as a continuous intravenous infusion over 3 hours. The dose will be increased every 10 minutes from 10 μg/kg/day, to a maximum of 80 μg/kg/day and then decreased to 30 μg/kg/day. Blood samples will be taken for the measurement of biomarkers and serelaxin levels during visits 2 and 3.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1636
Date of REC Opinion
24 Nov 2015
REC opinion
Further Information Favourable Opinion