Phase 3
Completed N=12
The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution
Hypertension · Congestive Cardiomyopathy
Source: ClinicalTrials.gov NCT00741156 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcomePrimary: Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat — 1.4; 1.8; 1.9; 1.9 l/min/m2 — p=0.09
Summary
The primary objective of this study is to study the acute effects of angiotensin-converting enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional cavopulmonary connection (BCPC) patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Systemic, Pulmonary and Cerebral Blood Flow at Baseline and After Enalaprilat |
1.4; 1.8; 1.9; 1.9; 1.9; 1.8 | 0.09 |
| PRIMARY Systemic, Pulmonary and Cerebral Resistance at Baseline and After Enalaprilat |
40.94; 20.26; 2.87; 2.54; 24.07; 17.32 | — |
Eligibility Criteria
Inclusion Criteria
- BCPC patients at time of routine pre-Fontan catheterization
- Patients between the ages of 2 months and 5 years old
Exclusion Criteria
- Patients who have had ACEI therapy within 24 hours of the procedure
Data sourced from ClinicalTrials.gov (NCT00741156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.