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

Description

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.

Study Start Date

October, 30 2017

Estimated Completion Date

March 2020

Interventions

  • Drug: Macitentan
  • Drug: Placebo

Study ID

Actelion -- AC-055G202

Status

Recruiting

Trial ID

NCT03153111

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

300

Sponsor

Actelion

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (53)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Principal Investigator 617-726-8228 glewis@partners.org
Weill Cornell Medicine - New York, New York 184.8 miles Principal Investigator 212-746-2381 pag9051@med.cornell.edu
Lehigh Valley Health Network - Allentown, Pennsylvania 257.9 miles Principal Investigator 610-402-9543 Ron.Freudenberger@lvhn.org
Drexel University College of Medicine - Philadelphia, Pennsylvania 269.6 miles Principal Investigator 215-762-4588 shankins@drexelmed.edu
Drexel University College of Medicine - Philadelphia, Pennsylvania 269.6 miles Principal Investigator 215-762-4588 shankins@drexelmed.edu
Drexel University College of Medicine - Philadelphia, Pennsylvania 269.6 miles Principal Investigator 215-762-4588 shankins@drexelmed.edu
Inova Heart and Vascular Institute - Falls Church, Virginia 401.4 miles Principal Investigator 703-776-4153 mardi.gomberg@inova.org
Inova Heart and Vascular Institute - Falls Church, Virginia 401.4 miles Principal Investigator 703-776-4153 mardi.gomberg@inova.org
Inova Heart and Vascular Institute - Falls Church, Virginia 401.4 miles Principal Investigator 703-776-4153 mardi.gomberg@inova.org
Inova Heart and Vascular Institute - Falls Church, Virginia 401.4 miles Principal Investigator 703-776-4153 mardi.gomberg@inova.org
Inova Heart and Vascular Institute - Falls Church, Virginia 401.4 miles Principal Investigator 703-776-4153 mardi.gomberg@inova.org
Allegheny General Hospital of Research Cardiology Institute - Pittsburgh, Pennsylvania 480.9 miles Principal Investigator 412-359-4760 rbenza@wpahs.org
Allegheny General Hospital of Research Cardiology Institute - Pittsburgh, Pennsylvania 480.9 miles Principal Investigator 412-359-4760 rbenza@wpahs.org
Allegheny General Hospital of Research Cardiology Institute - Pittsburgh, Pennsylvania 480.9 miles Principal Investigator 412-359-4760 rbenza@wpahs.org
Allegheny General Hospital of Research Cardiology Institute - Pittsburgh, Pennsylvania 480.9 miles Principal Investigator 412-359-4760 rbenza@wpahs.org
Allegheny General Hospital of Research Cardiology Institute - Pittsburgh, Pennsylvania 480.9 miles Principal Investigator 412-359-4760 rbenza@wpahs.org
University of North Carolina at Chapel Hill School of Medicine - Chapel Hill, North Carolina 616.4 miles Principal Investigator 919-843-9996 lisa_rose-jones@med.unc.edu
AnMed Health - Anderson, South Carolina 827.4 miles Principal Investigator 854-512-5667 drravallung@gmail.com
AnMed Health - Anderson, South Carolina 827.4 miles Principal Investigator 854-512-5667 drravallung@gmail.com
AnMed Health - Anderson, South Carolina 827.4 miles Principal Investigator 854-512-5667 drravallung@gmail.com
Northwestern University Feinberg School of Medicine Cardiology - Chicago, Illinois 847.9 miles Principal Investigator 312-695-0993 bfreed@nm.org
Northwestern University Feinberg School of Medicine Cardiology - Chicago, Illinois 847.9 miles Principal Investigator 312-695-0993 bfreed@nm.org
Northwestern University Feinberg School of Medicine Cardiology - Chicago, Illinois 847.9 miles Principal Investigator 312-695-0993 bfreed@nm.org
Northwestern University Feinberg School of Medicine Cardiology - Chicago, Illinois 847.9 miles Principal Investigator 312-695-0993 bfreed@nm.org
Northwestern University Feinberg School of Medicine Cardiology - Chicago, Illinois 847.9 miles Principal Investigator 312-695-0993 bfreed@nm.org
Washington University School of Medicine - Saint Louis, Missouri 1,039.5 miles Principal Investigator 314-454-8766 chakinalam@wustl.edu
North Dallas Research Associates - McKinney, Texas 1,526.5 miles Principal Investigator 972-562-2345 arhum2000@gmail.com
North Dallas Research Associates - McKinney, Texas 1,526.5 miles Principal Investigator 972-562-2345 arhum2000@gmail.com
North Dallas Research Associates - McKinney, Texas 1,526.5 miles Principal Investigator 972-562-2345 arhum2000@gmail.com
North Dallas Research Associates - McKinney, Texas 1,526.5 miles Principal Investigator 972-562-2345 arhum2000@gmail.com
North Dallas Research Associates - McKinney, Texas 1,526.5 miles Principal Investigator 972-562-2345 arhum2000@gmail.com
Baylor Scott White - Temple, Texas 1,644.2 miles Principal Investigator 254-724-5861 Albert.Hicks@BSWHealth.org
Baylor Scott White - Temple, Texas 1,644.2 miles Principal Investigator 254-724-5861 Albert.Hicks@BSWHealth.org
Baylor Scott White - Temple, Texas 1,644.2 miles Principal Investigator 254-724-5861 Albert.Hicks@BSWHealth.org
Baylor Scott White - Temple, Texas 1,644.2 miles Principal Investigator 254-724-5861 Albert.Hicks@BSWHealth.org
Baylor Scott White - Temple, Texas 1,644.2 miles Principal Investigator 254-724-5861 Albert.Hicks@BSWHealth.org
South Denver Cardiology Associates PC - Littleton, Colorado 1,771.5 miles Principal Investigator 303-715-2210 idauber@southdenver.com
South Denver Cardiology Associates PC - Littleton, Colorado 1,771.5 miles Principal Investigator 303-715-2210 idauber@southdenver.com
South Denver Cardiology Associates PC - Littleton, Colorado 1,771.5 miles Principal Investigator 303-715-2210 idauber@southdenver.com
South Denver Cardiology Associates PC - Littleton, Colorado 1,771.5 miles Principal Investigator 303-715-2210 idauber@southdenver.com
South Denver Cardiology Associates PC - Littleton, Colorado 1,771.5 miles Principal Investigator 303-715-2210 idauber@southdenver.com
Mayo Clinic Arizona Cardiology Department - Phoenix, Arizona 2,284.5 miles Principal Investigator 480-342-2376 scott.robert@mayo.edu
Mayo Clinic Arizona Cardiology Department - Phoenix, Arizona 2,284.5 miles Principal Investigator 480-342-2376 scott.robert@mayo.edu
Mayo Clinic Arizona Cardiology Department - Phoenix, Arizona 2,284.5 miles Principal Investigator 480-342-2376 scott.robert@mayo.edu
Mayo Clinic Arizona Cardiology Department - Phoenix, Arizona 2,284.5 miles Principal Investigator 480-342-2376 scott.robert@mayo.edu
Mayo Clinic Arizona Cardiology Department - Phoenix, Arizona 2,284.5 miles Principal Investigator 480-342-2376 scott.robert@mayo.edu
MultiCare Institute for Research Innovation - Tacoma, Washington 2,500.9 miles Principal Investigator 253-403-7258 ahmadmslim@gmail.com
MultiCare Institute for Research Innovation - Tacoma, Washington 2,500.9 miles Principal Investigator 253-403-7258 ahmadmslim@gmail.com
MultiCare Institute for Research Innovation - Tacoma, Washington 2,500.9 miles Principal Investigator 253-403-7258 ahmadmslim@gmail.com
MultiCare Institute for Research Innovation - Tacoma, Washington 2,500.9 miles Principal Investigator 253-403-7258 ahmadmslim@gmail.com
MultiCare Institute for Research Innovation - Tacoma, Washington 2,500.9 miles Principal Investigator 253-403-7258 ahmadmslim@gmail.com
San Diego Cardiac Center - San Diego, California 2,579.1 miles Principal Investigator 858-244-6886 hmehta@sdcardiac.com
Cedars Sinai Heart Institute - Beverly Hills, California 2,601.9 miles Principal Investigator 310-248-8300 Antoine.Hage@cshs.org

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