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



Status:Recruiting
Conditions:Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:December 21, 2017
End Date:May 18, 2020

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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.


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.
We found this trial at
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-7260
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-726-8228
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Allentown, Pennsylvania 18105
Phone: 610-402-9543
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Anderson, South Carolina 29621
Phone: 854-512-5667
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Apex, North Carolina 27502
Phone: 919-267-5209
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Beverly Hills, California 90211
Phone: 310-248-8300
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Chapel Hill, North Carolina 27599
Phone: 919-843-9996
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420 East Superior Street
Chicago, Illinois 60611
Phone: 312-695-0993
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Cincinnati, Ohio 45219
Phone: 513-206-1220
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Falls Church, Virginia 22042
Phone: 703-776-4153
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200 Hawkins Drive
Iowa City, Iowa 52242
Phone: 319-335-4873
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Littleton, Colorado 80120
Phone: 303-715-2210
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McKinney, Texas 75069
Phone: 972-562-2345
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
414-649-6000
Phone: 414-646-2438
Aurora St. Luke's Medical Center At Aurora St. Luke's Medical Center, you'll find remarkable treatment...
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New York, New York 10065
Phone: 212-746-2381
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2900 W Queen Ln
Philadelphia, Pennsylvania 19129
(215) 991-8100
Phone: 215-762-4588
Drexel University College of Medicine Drexel University College of Medicine represents the consolidation of two...
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5777 East Mayo Boulevard
Phoenix, Arizona 85054
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320 East North Avenue
Pittsburgh, Pennsylvania 15212
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Pittsburgh, Pennsylvania 15213
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Phone: 314-454-8766
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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7901 Frost Street
San Diego, California 92123
858-939-3400
Phone: 858-244-6886
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Tacoma, Washington 98405
Phone: 253-403-7258
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Temple, Texas 76504
Phone: 254-724-5861
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Washington, District of Columbia
Phone: 202-877-2339
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