Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Phase 3

Terminated

• Conditions: Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Failure, Congestive
• Interventions: Other: Placebo; Drug: Enalapril

• Registration Number: NCT00113698
• Lead Sponsor: University of Utah

Brief 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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-06-09
• Study First Submitted QC: 2005-06-09
• Study First Posted: 2005-06-10
• Primary Completion: 2005-11
• Study Completion: 2006-01
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-11
• Last Update Posted: 2014-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Children less than 18 years of age and at least 6 months post AVSD repair or reoperation
• At least moderate MR
• Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II
• Atrioventricular synchrony (paced or intrinsic)

Exclusion Criteria

• Tetrology of Fallot, total or partial anomalous venous connection
• More than trivial MS or outflow obstruction
• Other sources of LV volume overload
• Hypertrophic obstructive cardiomyopathy
• Significant residual coarctation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	-
2	Enalapril	Ace inhibition (enalapril)

Primary Outcome Measures

Name	Time	Method
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size	Measured after six months of therapy

Secondary Outcome Measures

Name	Time	Method
Comparison of the effect of ACE-I therapy with placebo on MR severity, left ventricular geometry, hemodynamics, and signs and symptoms of congestive heart failure	6 months on study drug
Evaluation of the early natural history of MR in the six months after repair of an AVSD	6 months on study drug
Comparison of the incidence of adverse events occurring in subjects treated with ACE-I therapy to that in subjects receiving placebo (measured after six months of therapy)	6 months on safety drug

Trial Locations

Locations (7)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Columbia College of Physicians and Surgeons; 🇺🇸 New York, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States