Angiotensin Converting Enzyme Inhibition in Children With Mitral Regurgitation

Heart Failure, Congestive Clinical Trial

— AceiMR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00113698
• Other study ID #: 185
• Secondary ID: U01HL068269U01HL
• Status: Terminated
• Phase: Phase 3
• First received: June 9, 2005
• Last updated: March 11, 2014
• Start date: December 2004
• Est. completion date: January 2006

Study information

• 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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Abnormalities
• Heart Defects, Congenital
• Heart Failure
• Heart Failure, Congestive
• Heart Septal Defects
• Heart Septal Defects, Ventricular
• Mitral Valve Insufficiency

Intervention

Drug:
• Enalapril
Up-titration period is to reach the highest tolerated dose up to a maximum of 0.4 mg/kg/day

Other:
• Placebo
Placebo An inert preparation with similar appearance and taste to the drug

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University of Utah	National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

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