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

Completed · Phase 2 · Has a placebo group

Conditions studied: Heart Failure With Preserved Ejection Fraction

In brief

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.

Key facts

Study ID

NCT03153111

Run by

Actelion

People needed

143

Starts

2017-07-11

Expected to finish

2021-03-12

Last updated by the study team

2025-03-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Weill Cornell Medicine — New York, New York, United States
• Peak Clinical Trials — Apex, North Carolina, United States
• University of North Carolina (UNC) - School of Medicine — Chapel Hill, North Carolina, United States
• The Lindner Clinical Trial Center — Cincinnati, Ohio, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Drexel University College of Medicine — Philadelphia, Pennsylvania, United States
• Allegheny — Pittsburgh, Pennsylvania, United States
• Vascular Medicine Institute University Of Pittsburgh — Pittsburgh, Pennsylvania, United States
• AnMed Health — Anderson, South Carolina, United States
• North Dallas Research Associates — McKinney, Texas, United States
• Baylor Scott and White Research Institute — Temple, Texas, United States
• Inova Heart and Vascular Institute — Falls Church, Virginia, United States
• MultiCare Health System — Tacoma, Washington, United States
• Aurora Saint Lukes Medical Center — Milwaukee, Wisconsin, United States
• Centro Médico Dra. De Salvo — Buenos Aires, Argentina
• Mayo Clinic Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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