NCT00113698

Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).

Detailed description

BACKGROUND: MR causes volume overload and hemodynamic burden on the left ventricle. Initial compensatory mechanisms may fail, leading to increased severity. Patients who have had repair of an atrioventricular septal defect (AVSD) are selected for this study as they have a relatively high incidence of moderate MR and their regurgitant orifice is mobile and dynamic, contributing to the likelihood that they might respond to medical therapy. DESIGN NARRATIVE: This is a randomized, double-blind, placebo-controlled trial of ACE-I therapy in children less than 18 years of age with at least moderate MR who are at least 6 months postoperative from repair of an AVSD. A non-randomized Observational Phase enrolled 181 children who were less than 6 months postoperative from repair of an AVSD, who were then evaluated at 6 months for trial eligibility.

Conditions

• Heart Defects, Congenital
• Heart Septal Defects, Ventricular
• Heart Failure, Congestive

Interventions

Type	Name	Description
DRUG	Enalapril	Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
OTHER	Placebo	Placebo An inert preparation with similar appearance and taste to the drug

Timeline

• Start date: 2004-12-01
• Primary completion: 2005-11-01
• Completion: 2006-01-01
• First posted: 2005-06-10
• Last updated: 2014-03-13

Locations

7 sites across 2 countries: United States, Canada