This study will evaluate the efficacy and safety of ACE inhibition therapy for the treatment of mitral regurgitation.

Primary Outcome: To compare the effect of ACE-I therapy to that of placebo on left ventricular size after 6 months of therapy.

Secondary Outcomes: To compare the effect of ACE-I therapy to placebo on MR severity, left ventricular geometry, hemodynamics as well as signs and symptoms of congestive heart failure. To evaluate the early natural history of MR in the 6 months after repair of an atrioventricular septal defect. To compare the incidence of adverse events occurring in subjects treated with ACE-I therapy to that in subjects receiving placebo.

Condition	Intervention	Phase
Defect, Congenital Heart Heart Septal Defects, Ventricular Heart Failure, Congestive	Drug: Enalapril (ACE inhibitor)	Phase III

Further Study Details: 

BACKGROUND: Mitral regurgitation (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 (ASVD) 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 mitral regurgitation who are at least 6 months postoperative from repair of an atrioventricular septal defect.

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both

Criteria

Children < 18 years of age and at least 6 months post atrioventricular septal defect repair or reoperation.

At least moderate mitral regurgitation.

Asymptomatic or minimally symptomatic, defined by Ross Heart Failure Class I or II.

Atrioventricular synchrony (paced or intrinsic).

Please refer to this study by ClinicalTrials.gov identifier  NCT00113698

Massachusetts
      Children''''s Hospital Boston, Boston,  Massachusetts,  United States; Recruiting
New York
      Columbia College of Physicians and Surgeons, New York,  New York,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  United States; Recruiting
Pennsylvania
      Children''''s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  United States; Recruiting
Utah
      Primary Children''''s Hospital, Salt Lake City,  Utah,  United States; Recruiting
Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  Canada; Recruiting

Study ID Numbers:  185
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 9, 2005
ClinicalTrials.gov Identifier:  NCT00113698
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05