Trial of Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation After Repair of Atrioventricular Septal Defect--Pediatric Heart Network

Condition(s) targeted: Heart Defects, Congenital; Heart Septal Defects, Ventricular; Heart Failure, Congestive

Intervention: Enalapril (Drug); Placebo (Other)

Phase: Phase 3

Status: Terminated

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
LuAnn Minich, MD, Principal Investigator, Affiliation: Primary Children's Hospital, Salt Lake City, UT

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome:

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

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

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)

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.

Minimum age: N/A. Maximum age: 18 Years. Gender(s): Both.

Criteria:

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

Children's Hospital Boston, Boston, Massachusetts 02115, United States

Columbia College of Physicians and Surgeons, New York, New York 10032, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Primary Children's Hospital, Salt Lake City, Utah 84132, United States

Starting date: December 2004
Ending date: January 2006
Last updated: February 7, 2008