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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 : Completed
First Posted : May 15, 2017
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE May 15, 2017
Last Update Posted Date March 24, 2021
Actual Study Start Date  ICMJE July 11, 2017
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
Percent of baseline NT-proBNP assessed at Week 24 [ Time Frame: over 24 weeks (from baseline to Week 24) ]
Percent of baseline NT-proBNP assessed at Week 24
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2017)
  • Change from baseline to Week 24 in accelerometer-assessed proportion of time spent in light to vigorous physical activity based on a threshold of >100 activity counts per minute [ Time Frame: over 24 weeks (from baseline to Week 24) ]
    Change from baseline to Week 24 in accelerometer-assessed proportion of time spent in light to vigorous physical activity based on a threshold of >100 activity counts per minute
  • Change from baseline to Week 24 in the clinical summary score (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]) [ Time Frame: over 24 weeks (from baseline to Week 24) ]
    Change from baseline to Week 24 in the clinical summary score (as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ])
  • Time to worsening heart failure (WHF) event over 52 weeks [ Time Frame: over 52 weeks (from baseline to Week 24) ]
    Time to worsening heart failure (WHF) event over 52 weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure With Preserved Ejection Fraction
Intervention  ICMJE
  • Drug: Macitentan
    macitentan 10 mg; film-coated tablet; oral use
    Other Name: ACT-064992
  • Drug: Placebo
    film-coated tablet (identical to the macitentan tablet); oral use
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Macitentan
  • Placebo Comparator: Placebo
    Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2020)
143
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2017)
300
Actual Study Completion Date  ICMJE March 12, 2021
Actual Primary Completion Date March 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Austria,   Brazil,   Bulgaria,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT03153111
Other Study ID Numbers  ICMJE AC-055G202
2016-003653-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Actelion
Study Sponsor  ICMJE Actelion
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Actelion
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP