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

March 11, 2014 updated by: Lois LuAnn Minich, University of Utah

Trial of ACE Inhibition in Children With Mitral Regurgitation After Repair of AVSD

This study will evaluate the efficacy and safety of angiotensin converting enzyme inhibition (ACE-I) therapy for the treatment of mitral regurgitation (MR).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Hospital For Sick Children
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Children's Hospital Boston
    • New York
      • New York, New York, United States, 10032
        • Columbia College of Physicians and Surgeons
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Primary Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Other: Placebo
Placebo An inert preparation with similar appearance and taste to the drug
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size
Time Frame: Measured after six months of therapy
Measured after six months of therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
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
6 months on study drug
Evaluation of the early natural history of MR in the six months after repair of an AVSD
Time Frame: 6 months on study drug
6 months on study drug
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
6 months on safety drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network

Investigators

  • Principal Investigator: LuAnn Minich, MD, Primary Children's Hospital, Salt Lake City, UT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

June 9, 2005

First Submitted That Met QC Criteria

June 9, 2005

First Posted (Estimate)

June 10, 2005

Study Record Updates

Last Update Posted (Estimate)

March 13, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 185
  • U01HL068292 (U.S. NIH Grant/Contract)
  • U01HL068290 (U.S. NIH Grant/Contract)
  • U01HL068288 (U.S. NIH Grant/Contract)
  • U01HL068285 (U.S. NIH Grant/Contract)
  • U01HL068281 (U.S. NIH Grant/Contract)
  • U01HL068279 (U.S. NIH Grant/Contract)
  • U01HL068270 (U.S. NIH Grant/Contract)
  • U01HL068269 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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