Status:
TERMINATED
Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation
Lead Sponsor:
University of Utah
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Conditions:
Heart Defects, Congenital
Heart Septal Defects, Ventricular
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 atriove...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2006
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00113698
Start Date
December 1 2004
End Date
January 1 2006
Last Update
March 13 2014
Active Locations (7)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
3
Duke University Medical Center
Durham, North Carolina, United States, 27710
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104