SERENADE OL: Macitentan in HFpEF and Pulmonary Vascular Disease
Research type
Research Study
Full title
A long-term, multicentre, single-arm, open-label extension of the SERENADE study, to assess the safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease.
IRAS ID
272307
Contact name
Gerry Coghlan
Contact email
Sponsor organisation
ACTELION Pharmaceuticals Ltd
Eudract number
2018-001603-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
6 years, 3 months, 28 days
Research summary
Summary of Research
Heart failure is a common, disabling and potentially fata condition which is the leading cause of hospitalization 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.Heart failure with preserved ejection fraction (HFpEF)is estimated to affect 40% to 71% of all heart failure patients 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, diabetes mellitus, obesity, anemia, chronic kidney disease, atrial fibrillation, and chronic obstructive pulmonary disease, all of which contribute to mortality.
The Serenade Open-Label(OL)study is an extension to the Serenade, 52 week, Double-Blind (DB) study (AC-055G202), and is open to participants who have completed 52 weeks in the study.
All eligible participants will continue to receive the same study treatment as that used in the DB study - 10mg of Macitentan (ACT-064992, Opsumit®), taken orally, once a day. Enrolment into the OL study may take place on the same day as the end of study visit in the DB study.
Macitentan is already approved for the treatment of pulmonary arterial hypertension (PAH). Current heart failure therapy is largely based on digitalis and diuretics associated with various combinations of reninangiotensin-aldosterone system (RAAS)- and beta blockers.
In contrast to HFpEF, 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.
The main objective of the study is to describe the long term safety of Macitentan 10mg in patients with HFpEF. The secondary aim is to explore long term efficacy of Macitentan 10mg.
Summary of Final Research
N/A
REC name
Wales REC 1
REC reference
19/WA/0294
Date of REC Opinion
31 Oct 2019
REC opinion
Further Information Favourable Opinion