Heart Failure, Congestive Clinical Trial
— AceiMROfficial title:
Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD
Verified date | March 2014 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).
Status | Terminated |
Enrollment | 5 |
Est. completion date | January 2006 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Hospital for Sick Children | Toronto | Ontario |
United States | Children's Hospital Boston | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Columbia College of Physicians and Surgeons | New York | New York |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Primary Children's Hospital | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size | Measured after six months of therapy | Yes | |
Secondary | 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 | Yes | |
Secondary | Evaluation of the early natural history of MR in the six months after repair of an AVSD | 6 months on study drug | Yes | |
Secondary | 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 | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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