ACE inhibition in Fontan patients: its effect on body fluid regulation.
Recruiting
- Conditions
- Fontan patients/palliation/circulation/surgery<br />Single ventricle, univentricular heart<br />ACE-inhibition, Enalapril
- Registration Number
- NL-OMON27721
- Lead Sponsor
- eiden University Medical Centre (LUMC)
- Brief Summary
Harteveld LM, Blom NA, Terol C, Kuipers IM, Rammeloo LAJ, Hazekamp MG, Van Dijk JG, Ten Harkel ADJ. 3-month Enalapril Treatment in Pediatric Fontan Patients with Moderate to Good Systolic Ventricular Function. Am J Cardiol. 2021 Nov 10:S0002-9149(21)01007-9 Harteveld LM, Blom NA, Terol C, Van Dijk JG, Kuipers IM, Rammeloo LAJ, De Geus EJC, Hazekamp MG, Ten Harkel ADJ. Determinants of exercise limitation in contemporary paediatric Fontan patients with an extra cardiac conduit. Int J Cardiol. 2021 Oct 15;341:31-38. Two other following (submitted)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
Patients with a univentricular heart after palliation with the Fontan circulation from 8-18 years old.
Exclusion Criteria
Patients who already use ACE-inhibition.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Cardiopulmonary exercise stress test: VO2peak.<br /><br>- Cardiac autonomic nervous activity: heart rate variability and pre-ejection period.<br /><br>- Outcome of passive leg raising and head up tilt table testing: cardiac output and cardiac autonomic tone.
- Secondary Outcome Measures
Name Time Method