Angiotensin-Converting Enzyme (ACE) inhibitor cessation in the setting of well-functioning Fontan hearts

Not Applicable

Recruiting

• Conditions: congenital heart defect; Surgery - Other surgery; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12618000204246
• Lead Sponsor: Prof Yves d'Udekem

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-08
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Have a Fontan circulation
2. Are taking ACEI or ARB medication for 12 months or more.
3. Can perform a cardiopulmonary exercise test on a cycle ergometer.

Exclusion Criteria

1. Have worse than normal ventricular function.
2. Have greater than mild atrio-ventricular or aortic valve regurgitation.
3. Have systemic hypertension.
4. Have a physical or intellectual impairment preventing exercise testing.
5. Are pregnant or intending to get pregnant during the study period or have been pregnant beyond the first trimester within 12 months prior to study recruitment..

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VO2 peak within 5% range measured by cardiopulmonary exercise testing.[At baseline and at 12 month visits for each arm]