Heart Defects, Congenital, Heart Failure, Congestive, Heart Septal Defects, Ventricular
Conditions
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.
Interventions
DRUGEnalapril
Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
OTHERPlacebo
Placebo An inert preparation with similar appearance and taste to the drug
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size | Measured after six months of therapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada, United States
Outcome results
None listed