Evaluation of the effect from ACE inhibition on body fluid regulation in children with a Fontan circulation (a circulation in which it lacks a heart chamber that pumps the blood througt the lung circulation).
Phase 1
- Conditions
- Patients with univentricular hearts palliated by the Fontan procedureTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-004433-24-NL
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 92
Inclusion Criteria
Fontan patiënts
Patiënts from 8 until 18 years old
Are the trial subjects under 18? yes
Number of subjects for this age range: 92
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Fontan patients who already use enalapril
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method