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

Royal Adelaide Hospital

Adelaide,

Phone: +61 8 8222 4000

from

Adelaide,