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
NCT ID: NCT03153111
Last Updated: 2025-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
143 participants
INTERVENTIONAL
2017-07-11
2021-03-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Macitentan
Subjects randomized to the macitentan arm receives one tablet of macitentan 10 mg every day for at least 24 to maximum 52 weeks.
Macitentan
macitentan 10 mg; film-coated tablet; oral use
Placebo
Subjects randomized to the placebo arm received one tablet of placebo every day for at least 24 to maximum 52 weeks.
Placebo
film-coated tablet (identical to the macitentan tablet); oral use
Interventions
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Macitentan
macitentan 10 mg; film-coated tablet; oral use
Placebo
film-coated tablet (identical to the macitentan tablet); oral use
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Locations
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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
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
CCBR - Buenos Aires - AR
Buenos Aires, , Argentina
Clinica Adventista Belgrano
CABA, , Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, , Argentina
Medizinische Universitaet Wien
Vienna, , Austria
Maestri E Kormann Consultoria Médico- Científica Ltda
Blumenau, , Brazil
Rede D or Sao Luiz S A Hospital do Coracao do Brasil
Brasília, , Brazil
Instituto de Pesquisa Clinica de Campinas
Campinas, , Brazil
Instituto do Coracao de Marília
Marília, , Brazil
Instituto de Moléstias Cardiovasculares Tatuí
Tatuí, , Brazil
Specialized Hospital for Active Treatment in Cardiology - Pleven
Pleven, , Bulgaria
Diagnostic Consulting Center I Sliven
Sliven, , Bulgaria
Multiprofile Hospital for Active Treatment - National Heart Hospital
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, , Bulgaria
Fakultni nemocnice Brno
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
University Hospital Plzeň-Lochotín
Pilsen, , Czechia
General University Hospital II.department of Internal Medicine-cardiology and angiology
Prague, , Czechia
IKEM
Prague, , Czechia
Aarhus Universitetshospital
Aarhus, , Denmark
Bispebjerg Og Frederiksberg Hospital
Copenhagen, , Denmark
Sydvestjysk Sygehus
Esbjerg, , Denmark
Hopital Henri Mondor
Créteil, , France
CHU de Grenoble Hopital Albert Michallon
Grenoble, , France
Hopital de Bicetre
Le Kremlin-Bicêtre, , France
Hopital Cardiologique
Lille, , France
CHU Rouen Hopital Charles Nicolle
Rouen, , France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, , Germany
Universitatsklinikum Bonn
Bonn, , Germany
Herzzentrum Uniklinik Köln Klinik III für Innere Medizin
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie
Dresden, , Germany
Universitaetsklinikum Giessen
Giessen, , Germany
Universitaetsklinikum Schleswig Holstein Campus Kiel
Kiel, , Germany
Klinikum Würzburg Mitte gGmbH Standort Missioklinik
Würzburg, , Germany
Budai Irgalmasrendi Korhaz
Budapest, , Hungary
Semmelweis Egyetem Varosmajor Sziv es Ergyogyaszati Klinika
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Bnai Zion Medical Center
Haifa, , Israel
Wolfson Medical Center
Holon, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center Beilinson Campus
Petah Tikva, , Israel
Kaplan Medical Center
Rehovot, , Israel
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, , Poland
4 Wojskowy Szpital Kliniczny Z Poliklinika SP ZOZ
Wroclaw, , Poland
Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu
Bucharest, , Romania
Cardiomed
Craiova, , Romania
SAL MED Pitesti
Piteşti, , Romania
Cmi Dr Podoleanu Cristian
Târgu Mureş, , Romania
Federal State Budget Scientific Institution
Kemerovo, , Russia
Krasnodar Regional Clinical Hospital
Krasnodar, , Russia
Moscow City Clinical Hospital No.51
Moscow, , Russia
National Medical Research Center of Cardiology of MoH of Russian Federation
Moscow, , Russia
Federal State Budgetary Institution
Saint Petersburg, , Russia
State Healthcare Institution, Regional Clinical Cardiology Dispensary
Saratov, , Russia
State Autonomous Healthcare Institution Of Yaroslavl Region
Yaroslavl, , Russia
Ekaterinburg City Clinical Hospital #14
Yekaterinburg, , Russia
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, , Sweden
Royal Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
Castle Hill Hospital
Cottingham, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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Shah SJ, Bonderman D, Borlaug BA, Cleland JGF, Lack G, Lu W, Voors AA, Zannad F, Gladwin MT. Macitentan for Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Pulmonary Vascular Disease: Results of the SERENADE Randomized Clinical Trial and Open-Label Extension Study. Circ Heart Fail. 2025 Mar;18(3):e011381. doi: 10.1161/CIRCHEARTFAILURE.123.011381. Epub 2025 Mar 11.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003653-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AC-055G202
Identifier Type: -
Identifier Source: org_study_id
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