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

Status:	Recruiting
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	12 - Any
Updated:	3/22/2019
Start Date:	December 7, 2017
End Date:	March 28, 2020

Prospective, Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Assessing the Efficacy and Safety of Macitentan in Fontan-palliated Adult and Adolescent Subjects.

The primary objective is to assess the effect of macitentan 10 mg as compared to placebo on
exercise capacity through cardiopulmonary exercise testing.

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

We found this trial at

sites

Nationwide Children's Hospital

700 Childrens Drive
Columbus, Ohio 43205

(616) 722-2000