Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Congenital Heart Disease Heart Diseases Heart Defects, Congenital Macitentan Macitentan 10 mg

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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 CAN'T join 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

Locations

  • UCLA
    Los Angeles California 90095 United States
  • Providence Medical Research Providence Health Care
    Spokane Washington 99202 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Actelion
ID
NCT03153137
Phase
Phase 3
Study Type
Interventional
Last Updated