Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Phase 3TerminatedNCT00113698

University of Utah5 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

EnalaprilDRUG

Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day

PlaceboOTHER

Placebo An inert preparation with similar appearance and taste to the drug

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Children's Hospital Boston

Boston, Massachusetts, United States

Columbia College of Physicians and Surgeons

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size

Time frame: Measured after six months of therapy

Secondary Outcomes

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

Time frame: 6 months on study drug

Evaluation of the early natural history of MR in the six months after repair of an AVSD

Time frame: 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)

Time frame: 6 months on safety drug

Data from ClinicalTrials.gov

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