Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-01-31

Brief Summary

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

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

2

Ace inhibition (enalapril)

Group Type ACTIVE_COMPARATOR

Enalapril

Intervention Type DRUG

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

Interventions

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Enalapril

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No