Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153111
Recruitment Status : Active, not recruiting
First Posted : May 15, 2017
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Actelion

Brief Summary:

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 143 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Macitentan

Arm Intervention/treatment
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.
Drug: Macitentan
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.
Drug: Placebo
film-coated tablet (identical to the macitentan tablet); oral use




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signs or symptoms of Heart Failure (HF) (NYHA FC I I and II I ) requiring treatment with at least one oral diuretic (any type)
  • Left ventricular ejection fraction (LVEF) ≥ 40% (by echocardiography at Screening)
  • Structural heart disease consistent with heart failure with preserved ejection fraction (HFpEF) established by echocardiography at Screening
  • Elevated NT-proBNP
  • Pulmonary vascular disease or right ventricular dysfunction

Exclusion Criteria:

  • Any prior valid measurement of LVEF < 40%. An echocardiogram is considered valid if its quality is sufficient to allow accurate assessment of LVEF and if it is reflective of the true status of the subject
  • Cardiovascular co-morbidities (e.g., significant unrepaired structural valvular heart disease; acute coronary syndrome, coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening; uncontrolled heart rate from atrial fibrillation or atrial flutter, history of serious life-threatening or hemodynamically significant arrhythmia; history of or anticipated heart transplant or ventricular assist device implantation, etc)
  • Systolic blood pressure (SBP) ≥ 180 mmHg, or diastolic blood pressure (DBP) ≥ 110 mmHg during Screening
  • Hemoglobin < 100g/L (< 10 g/dl) at Screening
  • Significant parenchymal lung disease (e.g., severe COPD, moderate or severe restrictive lung disease, diffuse interstitial fibrosis or alveolitis, pulmonary thromboembolism)
  • Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2
  • Severe hepatic impairment, e.g., Child Pugh Class C

Other protocol-defined inclusion/exclusion criteria may apply


Information from the National Library of Medicine

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


Locations
Show Show 95 study locations
Sponsors and Collaborators
Actelion
Additional Information:
Layout table for additonal information
Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT03153111    
Other Study ID Numbers: AC-055G202
2016-003653-15 ( EudraCT Number )
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Vascular Diseases
Heart Diseases
Cardiovascular Diseases
Macitentan
Endothelin A Receptor Antagonists
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Endothelin B Receptor Antagonists