Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
Overview
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Full Title of Study: “Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: November 2005
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
- Drug: Enalapril
- Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
- Other: Placebo
- Placebo An inert preparation with similar appearance and taste to the drug
Arms, Groups and Cohorts
- Placebo Comparator: 1
- Active Comparator: 2
- Ace inhibition (enalapril)
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: 18 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- University of Utah
- Collaborator
- National Heart, Lung, and Blood Institute (NHLBI)
- Provider of Information About this Clinical Study
- Principal Investigator: Lois LuAnn Minich, Primary Investigator – University of Utah
- Overall Official(s)
- LuAnn Minich, MD, Principal Investigator, Primary Children’s Hospital, Salt Lake City, UT
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.