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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 : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 7, 2018
Sponsor:
Information provided by (Responsible Party):
Actelion

March 30, 2017
May 15, 2017
June 7, 2018
December 21, 2017
May 18, 2020   (Final data collection date for primary outcome measure)
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

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
Complete list of historical versions of study NCT03153111 on ClinicalTrials.gov Archive Site
  • 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
  • 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 Kansas City Cardiomyopathy Questionnaire (KCCQ) is expressed as change from baseline to Week 24
  • Time to worsening heart failure (WHF) event over 52 weeks [ Time Frame: over 52 weeks (from baseline to Week 52) ]
    Worsening heart failure (WHF) event (yes/no) defined as signs and/or symptoms of heart failure requiring initiation or intensification of Heart Failure (HF) treatment over 52 weeks. Occurrence of a worsening HF (WHF) event will be assessed at each post-baseline study visit using the 2014 ACC/AHA definition [J Am Coll Cardiol. 2015;66(4):403-469].
  • 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
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure With Preserved Ejection Fraction
  • 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
  • Active Comparator: Macitentan
    Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for 52 weeks
    Intervention: Drug: Macitentan
  • Placebo Comparator: Placebo
    Subjects randomized to the placebo arm received one tablet of placebo every day for 52 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
Same as current
May 18, 2020
May 18, 2020   (Final data collection date for primary outcome measure)

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
  • HF hospitalization within 12 months prior to Screening and/or cardiac catheterization performed within 6 months prior to Screening showing PAWP or LVEDP > 15 mmHg
  • Elevated NT-proBNP
  • Pulmonary vascular disease or right ventricular dysfunction

Exclusion Criteria:

  • Any prior measurement of LVEF < 40%.
  • 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
  • Body mass index (BMI) ≥ 45 kg/m2
  • 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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Austria,   Bulgaria,   Czechia,   Denmark,   France,   Germany,   Hungary,   Israel,   Poland,   Romania,   Russian Federation,   Spain,   Sweden,   United Kingdom,   United States
 
 
NCT03153111
AC-055G202
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Actelion
Actelion
Not Provided
Not Provided
Actelion
June 2018

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