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Clinical trialNCT03714815TerminatedPhase 2Interventional

A Long Term Study to Find Out if Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease

SponsorActelionEnrollment91Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The aim of this open-label (OL) extension trial is to study the long-term safety and efficacy of macitentan in subjects with heart failure with preserved ejection fraction (HFpEF) and pulmonary vascular disease (PVD) beyond the treatment in the double-blind parent SERENADE study (AC-055G202, NCT03153111). Furthermore, this OL extension study will give eligible subjects of the main study (SERENADE/AC-055G202, NCT03153111) an opportunity to continue or start receiving macitentan.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

44 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Argentina
  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Argentina

Austria
  • Medizinische Universitaet Wien

    Vienna, Austria

Brazil
  • Maestri E Kormann Consultoria Médico- Científica Ltda

    Blumenau, Brazil

  • Instituto Do Coracao de Marília

    Marília, Brazil

Bulgaria
  • Diagnostic Consulting Center I Sliven

    Sliven, Bulgaria

  • Medical Centre Synexus

    Sofia, Bulgaria

Denmark
  • Bispebjerg Og Frederiksberg Hospital

    Copenhagen, Denmark

France
  • Chu de Grenoble Hopital Albert Michallon

    Grenoble, France

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, France

  • Chu Rouen Hopital Charles Nicolle

    Rouen, France

Germany
  • Universitätsklinikum Carl Gustav Carus Medizinische Klinik Und Poliklinik 1-Pneumologie

    Dresden, Germany

  • Universitaetsklinikum Giessen

    Giessen, Germany

  • Universitaetsklinikum Schleswig Holstein Campus Kiel

    Kiel, Germany

Hungary
  • Semmelweis Egyetem Varosmajor Sziv Es Ergyogyaszati Klinika

    Budapest, Hungary

Israel
  • Barzilai Medical Center

    Ashkelon, Israel

  • Hillel Yaffe Medical Center

    Hadera, Israel

  • Bnai Zion Medical Center

    Haifa, Israel

  • Galilee Medical Center

    Nahariya, Israel

  • Rabin Medical Center Beilinson Campus

    Petah Tikva, Israel

  • Kaplan Medical Center

    Rehovot, Israel

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

Romania
  • Cardiomed

    Craiova, Romania

  • Sal Med Pitesti

    Piteşti, Romania

  • Cmi Dr Podoleanu Cristian

    Târgu Mureş, Romania

Russia
  • Federal State Budget Scientific Institution

    Kemerovo, Russia

  • Moscow City Clinical Hospital No.51

    Moscow, Russia

  • Federal State Budgetary Institution

    Saint Petersburg, Russia

  • Ekaterinburg City Clinical Hospital #14

    Yekaterinburg, Russia

Sweden
  • Sahlgrenska Universitetsjukhuset

    Gothenburg, Sweden

United Kingdom
  • Royal Free Hospital

    London, United Kingdom

  • Sheffield Teaching Hospitals Nhs Foundation Trust Royal Hallamshire Hospital

    Sheffield, United Kingdom

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

  • Allegheny

    Pittsburgh, Pennsylvania, United States

4 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
7 Dec 2018
Primary completion
12 Oct 2021
Completion
12 Oct 2021
Last update posted
4 Feb 2025
Registered enrollment
91
Registry id
NCT03714815

Cross-registrations

EU-CTR / CTIS (EudraCT)2018-001603-37

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.