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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT03153111•Actelion

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (95)

Mayo Clinic Arizona

Phoenix, Arizona, United States

Cedars Sinai Heart Institute

Beverly Hills, California, United States

Sharp Memorial Hospital

San Diego, California, United States

Harbor Ucla Medical Center

Torrance, California, United States

South Denver Cardiology Associates PC

Littleton, Colorado, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

University Of Iowa - Hospitals & Clinics

Iowa City, Iowa, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

July 11, 2017

Primary Completion Date

March 12, 2021

Completion Date

March 12, 2021

Last Updated

March 30, 2025

Enrollment

143

ACTUAL participants

Conditions

Heart Failure With Preserved Ejection Fraction

Interventions

Macitentan

DRUG

Placebo

DRUG

Prospective Evaluation of AI-ECG for SHD Detection

NCT07057466

Valvular Heart Disease Stenosis and Regurgitation (Diagnosis)Pulmonary Hypertension (Diagnosis)+2 more

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RECRUITING

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

NCT07093528

Heart Failure With Preserved Ejection FractionCoronary Microvascular Dysfunction

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Prospective Evaluation of AI-ECG for SHD Detection

A Study Of CS Reducer For Symptomatic Heart Failure With HFpEF And CMD

A Safety, Tolerability, and Biomarker Trial of VS-041 in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF)

Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Fast Induced Remodeling in Heart Failure With Preserved Ejection Fraction

Assessment of CCM in HF With Higher Ejection Fraction