NCT00113698

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2004

Shorter than P25 for phase_3

Geographic Reach
2 countries

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2005

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

March 13, 2014

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

June 9, 2005

Last Update Submit

March 11, 2014

Conditions

Heart Defects, CongenitalHeart Septal Defects, VentricularHeart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • Comparison of the effect of ACE-I therapy with that of placebo on left ventricular size

    Measured after six months of therapy

Secondary Outcomes (3)

  • 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

  • Evaluation of the early natural history of MR in the six months after repair of an AVSD

    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)

    6 months on safety drug

Study Arms (2)

1

PLACEBO COMPARATOR
Other: Placebo

2

ACTIVE COMPARATOR

Ace inhibition (enalapril)

Drug: Enalapril

Interventions

EnalaprilDRUG

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

2
PlaceboOTHER

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

1

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Columbia College of Physicians and Surgeons

New York, New York, 10032, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84132, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

  • Li JS, Colan SD, Sleeper LA, Newburger JW, Pemberton VL, Atz AM, Cohen MS, Golding F, Klein GL, Lacro RV, Radojewski E, Richmond ME, Minich LL. Lessons learned from a pediatric clinical trial: the Pediatric Heart Network angiotensin-converting enzyme inhibition in mitral regurgitation study. Am Heart J. 2011 Feb;161(2):233-40. doi: 10.1016/j.ahj.2010.10.030.

    PMID: 21315203DERIVED

  • Atz AM, Hawkins JA, Lu M, Cohen MS, Colan SD, Jaggers J, Lacro RV, McCrindle BW, Margossian R, Mosca RS, Sleeper LA, Minich LL; Pediatric Heart Network Investigators. Surgical management of complete atrioventricular septal defect: associations with surgical technique, age, and trisomy 21. J Thorac Cardiovasc Surg. 2011 Jun;141(6):1371-9. doi: 10.1016/j.jtcvs.2010.08.093. Epub 2010 Dec 15.

    PMID: 21163497DERIVED

MeSH Terms

Conditions

Heart Defects, CongenitalHeart Septal Defects, VentricularHeart Failure

Interventions

Enalapril

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • LuAnn Minich, MD

    Primary Children's Hospital, Salt Lake City, UT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

June 9, 2005

First Posted

June 10, 2005

Study Start

December 1, 2004

Primary Completion

November 1, 2005

Study Completion

January 1, 2006

Last Updated

March 13, 2014

Record last verified: 2014-03

Locations

CA(1)US(6)