Clinical Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Subjects
The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on exercise capacity through cardiopulmonary exercise testing.
Study Start Date
November, 30 2017
Estimated Completion Date
- Drug: Placebo
- Drug: Macitentan 10 mg
Actelion -- AC-055H301
- 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
- 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
12 Years and older
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
|Massachusetts General Hospital Heart Center - Boston, Massachusetts||2.8 miles||Principal Investigatorfirstname.lastname@example.org|