Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
Completed · Phase 3 · Has a placebo group
Conditions studied: Congenital Heart Disease
In brief
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Key facts
- Study ID
- NCT03153137
- Run by
- Actelion
- People needed
- 142
- Starts
- 2017-08-14
- Expected to finish
- 2021-07-26
- Last updated by the study team
- 2025-03-30
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Written informed consent/assent from the subject and/or a legal representative prior to initiation of any study-mandated procedures
- Fontan-palliated subjects with either intra-atrial lateral tunnel total cavopulmonary connection (LT-TCPC), or extra cardiac tunnel TCPC (EC-TCPC) surgery > 1 year before Screening. Either LT- or EC-TCPC can be primary or secondary to atrio-pulmonary connection
- New York Heart Association (NYHA) functional class (FC) II or III (assessed by the investigator using the Specific Activity Scale
- Women of childbearing potential must have a negative serum pregnancy test use reliable contraception
You may not qualify if…
- Pattern of Fontan circulation severity
- Deterioration of the Fontan-palliated condition.
- Limitations to Cardiopulmonary exercise testing (CPET)
- Peak VO2 < 15 mL/kg/min.
- Any known factor or disease that may interfere with treatment compliance or full participation in the study
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
- UCLA — Los Angeles, California, United States
- Massachusetts General Hospital Heart Center — Boston, Massachusetts, United States
- Nationwide Children's Hospital — Columbus, Ohio, United States
- Texas Children's Hospital — Houston, Texas, United States
- Providence Medical Research Providence Health Care — Spokane, Washington, United States
- Royal Adelaide Hospital — Adelaide, Australia
- Royal Prince Alfred Hospital — Camperdown, Australia
- The Prince Charles Hospital, Adult Congenital Heart Disease Unit — Chermside, Australia
- Royal Children's Hospital — Parkville, Australia
- Queensland CHILDREN'S HOSPITAL — South Brisbane, Australia
- Westmead Hospital — Westmead, Australia
- CHU de Quebec Universite Laval — Québec, Quebec, Canada
- Beijing Anzhen Hospital — Beijing, China
- Beijing Fuwai Hospital — Beijing, China
- Shanghai Childrens Medical Center — Shanghai, China
- Wuhan Asia Heart Hospital — Wuhan, China
- Fakultni nemocnice v Motole — Prague, Czechia
- Rigshospitalet Kardiologisk Klinisk — Copenhagen, Denmark
- CHU Arnaud de Villeneuve — Montpellier, France
- Hôpital Necker - Enfants Malades — Paris, France
- Hôpital Cardiologique Du Haut-Lévêque — Pessac, France
- Deutsches Herzzentrum Berlinklinik Für Angeborene Herzfehler — Berlin, Germany
- Deutsches Herzzentrum München — München, Germany
- Auckland City Hospital — Auckland, New Zealand
Full record on ClinicalTrials.gov
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