Last updated on July 2020

Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Congenital Heart Disease
  • Age: Between 12 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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