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Sponsors and Collaborators: |
National Heart, Lung, and Blood Institute (NHLBI) Pediatric Heart Network |
Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00113698 |
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Condition | Intervention | Phase |
Heart Defects, Congenital Heart Septal Defects, Ventricular Heart Failure, Congestive |
Drug: Enalapril Other: Placebo |
Phase III |
MedlinePlus related topics: | Congenital Heart Defects Heart Failure |
ChemIDplus related topics: | Enalapril Enalapril maleate Enalaprilat |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD |
Enrollment: | 5 |
Study Start Date: | December 2004 |
Study Completion Date: | January 2006 |
Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Placebo Comparator |
Other: Placebo
Placebo
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2: Active Comparator
Ace inhibition (enalapril)
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Drug: Enalapril
Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
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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.
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Children's Hospital Boston | |||||
Boston, Massachusetts, United States, 02115 | |||||
United States, New York | |||||
Columbia College of Physicians and Surgeons | |||||
New York, New York, United States, 10032 | |||||
United States, North Carolina | |||||
Duke University Medical Center | |||||
Durham, North Carolina, United States, 27710 | |||||
United States, Pennsylvania | |||||
Children's Hospital of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, South Carolina | |||||
Medical University of South Carolina | |||||
Charleston, South Carolina, United States, 29425 | |||||
United States, Utah | |||||
Primary Children's Hospital | |||||
Salt Lake City, Utah, United States, 84132 | |||||
Canada, Ontario | |||||
Hospital for Sick Children | |||||
Toronto, Ontario, Canada, M5G 1X8 |
National Heart, Lung, and Blood Institute (NHLBI) |
Pediatric Heart Network |
Principal Investigator: | LuAnn Minich, MD | Primary Children's Hospital, Salt Lake City, UT |
Responsible Party: | New England Research Institutes ( Lynn Sleeper, ScD, PI ) |
Study ID Numbers: | 185, U01 HL068269, U01 HL068270, U01 HL068279, U01 HL068281, U01 HL068285, U01 HL068288, U01 HL068290, U01 HL068292 |
First Received: | June 9, 2005 |
Last Updated: | February 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00113698 |
Health Authority: | United States: Food and Drug Administration |
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