Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation (AceiMR)

This study has been terminated.
(lower than expected enrollment)
Sponsor:
Collaborators:
Pediatric Heart Network
Information provided by (Responsible Party):
Lois LuAnn Minich, University of Utah
ClinicalTrials.gov Identifier:
NCT00113698
First received: June 9, 2005
Last updated: March 11, 2014
Last verified: March 2014
  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 University of Utah:

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 An inert preparation with similar appearance and taste to the drug
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University of Utah
Pediatric Heart Network
Investigators
Principal Investigator: LuAnn Minich, MD Primary Children's Hospital, Salt Lake City, UT
  More Information

No publications provided by University of Utah

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lois LuAnn Minich, Primary Investigator, University of Utah
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, U01HL068292
Study First Received: June 9, 2005
Last Updated: March 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Septal Defects
Congenital Abnormalities
Heart Defects, Congenital
Heart Septal Defects, Ventricular
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Cardiovascular Abnormalities
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 October 01, 2014