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

PHASE2CompletedINTERVENTIONAL
Enrollment

143

Participants

Timeline

Start Date

July 11, 2017

Primary Completion Date

March 12, 2021

Study Completion Date

March 12, 2021

Conditions
Heart Failure With Preserved Ejection Fraction
Interventions
DRUG

Macitentan

macitentan 10 mg; film-coated tablet; oral use

DRUG

Placebo

film-coated tablet (identical to the macitentan tablet); oral use

Trial Locations (95)

1023

Budai Irgalmasrendi Korhaz, Budapest

1090

Medizinische Universitaet Wien, Vienna

1122

Semmelweis Egyetem Varosmajor Sziv es Ergyogyaszati Klinika, Budapest

1134

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1309

Multiprofile Hospital for Active Treatment - National Heart Hospital, Sofia

1750

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia

2400

Bispebjerg Og Frederiksberg Hospital, Copenhagen

5800

Specialized Hospital for Active Treatment in Cardiology - Pleven, Pleven

6700

Sydvestjysk Sygehus, Esbjerg

8200

Aarhus Universitetshospital, Aarhus

8800

Diagnostic Consulting Center I Sliven, Sliven

10021

Weill Cornell Medicine, New York

13353

Charite Universitatsmedizin Berlin Campus Virchow Klinikum, Berlin

15212

Allegheny, Pittsburgh

15261

Vascular Medicine Institute University Of Pittsburgh, Pittsburgh

18103

Lehigh Valley Health Network, Allentown

19102

Drexel University College of Medicine, Philadelphia

21201

University of Maryland, Baltimore

22042

Inova Heart and Vascular Institute, Falls Church

24105

Universitaetsklinikum Schleswig Holstein Campus Kiel, Kiel

27502

Peak Clinical Trials, Apex

27599

University of North Carolina (UNC) - School of Medicine, Chapel Hill

28007

Hospital General Universitario Gregorio Maranon, Madrid

28040

Hospital Clinico San Carlos, Madrid

29621

AnMed Health, Anderson

35392

Universitaetsklinikum Giessen, Giessen

38043

CHU de Grenoble Hopital Albert Michallon, Grenoble

46010

Hospital Clinico Universitario de Valencia, Valencia

46026

Hospital Universitario La Fe, Valencia

50937

Herzzentrum Uniklinik Köln Klinik III für Innere Medizin, Cologne

53105

Universitatsklinikum Bonn, Bonn

53215

Aurora Saint Lukes Medical Center, Milwaukee

59037

Hopital Cardiologique, Lille

60611

Northwestern University Feinberg School of Medicine, Chicago

63110

Washington University School Of Medicine, St Louis

75069

North Dallas Research Associates, McKinney

76031

CHU Rouen Hopital Charles Nicolle, Rouen

76508

Baylor Scott and White Research Institute, Temple

80120

South Denver Cardiology Associates PC, Littleton

85054

Mayo Clinic Arizona, Phoenix

90211

Cedars Sinai Heart Institute, Beverly Hills

90502

Harbor Ucla Medical Center, Torrance

92123

Sharp Memorial Hospital, San Diego

94010

Hopital Henri Mondor, Créteil

94270

Hopital de Bicetre, Le Kremlin-Bicêtre

97074

Klinikum Würzburg Mitte gGmbH Standort Missioklinik, Würzburg

98405

MultiCare Health System, Tacoma

110437

SAL MED Pitesti, Piteşti

121309

Moscow City Clinical Hospital No.51, Moscow

121552

National Medical Research Center of Cardiology of MoH of Russian Federation, Moscow

150003

State Autonomous Healthcare Institution Of Yaroslavl Region, Yaroslavl

197341

Federal State Budgetary Institution, Saint Petersburg

200505

Cardiomed, Craiova

350086

Krasnodar Regional Clinical Hospital, Krasnodar

410028

State Healthcare Institution, Regional Clinical Cardiology Dispensary, Saratov

540503

Cmi Dr Podoleanu Cristian, Târgu Mureş

620039

Ekaterinburg City Clinical Hospital #14, Yekaterinburg

650002

Federal State Budget Scientific Institution, Kemerovo

2210001

Galilee Medical Center, Nahariya

3339419

Bnai Zion Medical Center, Haifa

3810101

Hillel Yaffe Medical Center, Hadera

4941492

Rabin Medical Center Beilinson Campus, Petah Tikva

7610001

Kaplan Medical Center, Rehovot

9112001

Hadassah Medical Center, Jerusalem

52242-1081

University Of Iowa - Hospitals & Clinics, Iowa City

02114

Massachusetts General Hospital, Boston

45219-2906

The Lindner Clinical Trial Center, Cincinnati

C1426ABP

Centro Médico Dra. De Salvo, Buenos Aires

C1430CKE

CCBR - Buenos Aires - AR, Buenos Aires

C1430EGF

Clinica Adventista Belgrano, CABA

B7600FZN

Instituto de Investigaciones Clinicas Mar del Plata, Mar del Plata

89020-430

Maestri E Kormann Consultoria Médico- Científica Ltda, Blumenau

70390-700

Rede D or Sao Luiz S A Hospital do Coracao do Brasil, Brasília

13060-080

Instituto de Pesquisa Clinica de Campinas, Campinas

17515-000

Instituto do Coracao de Marília, Marília

18270-170

Instituto de Moléstias Cardiovasculares Tatuí, Tatuí

625 00

Fakultni nemocnice Brno, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

304 60

University Hospital Plzeň-Lochotín, Pilsen

128 08

General University Hospital II.department of Internal Medicine-cardiology and angiology, Prague

140 21

IKEM, Prague

01307

Universitätsklinikum Carl Gustav Carus Medizinische Klinik und Poliklinik 1-Pneumologie, Dresden

Unknown

Barzilai Medical Center, Ashkelon

Wolfson Medical Center, Holon

80 952

Uniwersyteckie Centrum Kliniczne, Gdansk

31 202

Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn, Krakow

20 718

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ, Lublin

50 513

4 Wojskowy Szpital Kliniczny Z Poliklinika SP ZOZ, Wroclaw

022328

Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu, Bucharest

08035

Hospital Vall d'Hebron, Barcelona

413 45

Sahlgrenska Universitetsjukhuset, Gothenburg

CB2 0AY

Royal Papworth Hospital NHS Foundation Trust, Cambridge

HU16 5JQ

Castle Hill Hospital, Cottingham

NW3 2QG

Royal Free Hospital, London

S10 2RX

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Actelion

INDUSTRY