A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease (SERENADE)
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|ClinicalTrials.gov Identifier: NCT03153111|
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : September 2, 2020
This is a study to evaluate whether macitentan is an effective and safe treatment for patients with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease.
The primary objective is to evaluate whether macitentan 10 mg reduces N-terminal pro-brain natriuretic peptide (NT-pro-BNP) as compared to placebo in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure With Preserved Ejection Fraction||Drug: Macitentan Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||143 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||July 11, 2017|
|Estimated Primary Completion Date :||December 9, 2020|
|Estimated Study Completion Date :||December 9, 2020|
Active Comparator: Macitentan
Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.
macitentan 10 mg; film-coated tablet; oral use
Other Name: ACT-064992
Placebo Comparator: Placebo
Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
film-coated tablet (identical to the macitentan tablet); oral use
- Change in NT-proBNP (Percent of Baseline Assessed at Week 24) [ Time Frame: Baseline and Week 24 ]Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular. response markers among all available surrogates in heart failure (HF). Changes in this marker may reflect reduction in cardiac load and left ventricular wall stress; reductions in NT-proBNP have been associated with improved outcomes in HF.
- Change From Baseline to Week 24 in the Clinical Summary Score (as Assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]) [ Time Frame: Baseline and Week 24 ]The clinical summary score (mean of physical limitation and total symptoms score) of the KCCQ is expressed as change from baseline to Week 24.
- Change from baseline to Week 24 in accelerometer-assessed physical activity [ Time Frame: Baseline and Week 24 ]Physical activity is assessed by accelerometer as the proportion of time spent in light to vigorous physical activity based on a threshold of >100 activity counts per minute and expressed as change from baseline to Week 24.
- Time to worsening heart failure (WHF) event over 52 weeks [ Time Frame: Baseline to Week 52 ]A WHF event includes heart failure (HF) death, hospitalization or an urgent visit for worsening HF.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153111