Phase 3 N=12 Treatment

The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution

Hypertension · Congestive Cardiomyopathy

Bottom Line

View on ClinicalTrials.gov: NCT00741156 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Enalaprilat (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: The Hospital for Sick Children
Primary completion: Jan 2010

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	—

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.

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

View full record on ClinicalTrials.gov →

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.