Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation (AceiMR)

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 3

Conditions: Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Failure, Congestive

Treatments: Drug: Enalapril; Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00113698

U01HL068292 (U.S. NIH Grant/Contract)

U01HL068270 (U.S. NIH Grant/Contract)

U01HL068290 (U.S. NIH Grant/Contract)

U01HL068288 (U.S. NIH Grant/Contract)

U01HL068281 (U.S. NIH Grant/Contract)

U01HL068269 (U.S. NIH Grant/Contract)

185

U01HL068285 (U.S. NIH Grant/Contract)

U01HL068279 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Treatment:

Other: Placebo

2

Active Comparator group

Description:

Ace inhibition (enalapril)

Treatment:

Drug: Enalapril