SERENADE: Macitentan in HFpEF and Pulmonary Vascular Disease
Research type
Research Study
Full title
A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease
IRAS ID
219279
Contact name
Gerry Coghlan
Contact email
Sponsor organisation
Actelion Pharmaceuticals Ltd
Eudract number
2016-003653-15
Clinicaltrials.gov Identifier
03153111
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Heart Failure is a common, disabling and potentially fatal condition, which is the leading pause of hospitalisation in people over the age of 65. Heart Failure is a major public health issue, which is estimated to affect over 23 million people worldwide.\nHeart failure with preserved ejection fraction (HFpEF) is estimated to affect 40% to 71% of all heart failure patient in different studies. Patients with HFpEF are predominantly elderly, more likely to be female than male, and have other conditions such as hypertension, coronary artery disease (CAD), diabetes mellitus, obesity, anemia, chronic kidney disease, atrial fibrillation, and chronic obstructive pulmonary disease, which contribute to mortality.\nThe treatment that this study proposed to use is Macitentan (ACT-064992, Opsumit®). This is a drug that is taken orally (10 mg once daily) and is already approved for the treatment of pulmonary arterial hypertension (PAH).\nCurrent Heart Failure therapy is largely based on digitalis and diuretics associated with various combinations of renin-angiotensin-aldosterone system (RAAS)- and beta blockers. In contrast to HFrEF, there is no approved therapy for HFpEF patients despite several attempts to mitigate the diastolic dysfunction through blockade of the RAAS, beta blockade and phosphodiesterase-5 (PDE-5) inhibitors. Today, HFpEF patients, particularly those with associated Pulmonary Hypertension, are usually treated for their underlying condition (e.g., hypertension, diabetes) and with diuretics for fluid retention.\nSubjects will be randomized in a 1:1 ratio to either macitentan or placebo. The duration of the study is planned to be approximately 2.5 years from first subject, first visit to last subject, last visit. There will be approximately 100 sites that have been planned in 15 countries.\nApproximately 375 subjects may need to enter the single-blind run-in period in order to achieve 300 randomized patients. With 25% screening failure rate prior to the run-in period, approximately 500 subjects may need to be screened for this trial.\n
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/1170
Date of REC Opinion
19 Jul 2017
REC opinion
Favourable Opinion