Trial of Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation After Repair of Atrioventricular Septal Defect--Pediatric Heart Network (AceiMR)
This study has been terminated.
(lower than expected enrollment)
Sponsor:
Collaborator:
Pediatric Heart Network
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00113698
First received: June 9, 2005
Last updated: February 11, 2009
Last verified: February 2009
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD |
Resource links provided by NLM:
Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):
Primary Outcome 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome 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 ] [ Designated as safety issue: Yes ]
- Evaluation of the early natural history of MR in the six months after repair of an AVSD [ Time Frame: 6 months on study drug ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| 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 |
|---|---|
| Placebo Comparator: 1 |
Other: Placebo
Placebo
Other Name: Placebo
|
|
Active Comparator: 2
Ace inhibition (enalapril)
|
Drug: Enalapril
Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day
Other Name: Enalapril
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00113698
Locations
| 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 | |
Sponsors and Collaborators
Pediatric Heart Network
Investigators
| Principal Investigator: | LuAnn Minich, MD | Primary Children's Hospital, Salt Lake City, UT |
More Information
No publications provided by National Heart, Lung, and Blood Institute (NHLBI)
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Lynn Sleeper, ScD, PI, New England Research Institutes |
| ClinicalTrials.gov Identifier: | NCT00113698 History of Changes |
| Other Study ID Numbers: | 185, U01 HL068269, U01 HL068270, U01 HL068279, U01 HL068281, U01 HL068285, U01 HL068288, U01 HL068290, U01 HL068292 |
| Study First Received: | June 9, 2005 |
| Last Updated: | February 11, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Congenital Abnormalities Heart Defects, Congenital Heart Failure Heart Septal Defects Heart Septal Defects, Ventricular Mitral Valve Insufficiency Endocardial Cushion Defects Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Heart Valve Diseases |
Enalapril Enalaprilat Angiotensin-Converting Enzyme Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013