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Variability of Ventricular Mass, Volume, & Ejection Fraction in Pediatric Cardiomyopathy Patients-Pediatric Heart Network (VVV)

This study has been completed.
Sponsor:
Collaborators:
Pediatric Heart Network
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00123071
First received: July 20, 2005
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

This observational study will provide data (variations in ventricular size and function) that are essential to designing and conducting clinical trials. In addition, the study will evaluate intra- and inter-study variability seen in echocardiography.


Condition
Cardiomyopathy, Dilated

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Variability of Ventricular Mass, Volume, and Ejection Fraction in Pediatric Cardiomyopathy Patients (A Study Conducted by the Pediatric Heart Network)

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Inter-study variability of echo measurements; variance at a single point in time and variance of change in measurements over time [ Time Frame: Measured for up to 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relative magnitude of the various sources of variability in echocardiographic outcomes in order to optimize operational procedures that can minimize variance [ Time Frame: Measured for up to 18 months ] [ Designated as safety issue: No ]
  • Interstudy variability of echocardiographically-derived indices of LV systolic and diastolic function derived from m-mode, spectral Doppler, and tissue Doppler techniques used in pediatric patients with dilated cardiomyopathy [ Time Frame: Measured for up to 18 months ] [ Designated as safety issue: No ]
  • Relationship of clinical status, including treatment, to the interstudy variability and repeatability of echocardiographic measurements. [ Time Frame: Measured for up to 18 months ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: May 2005
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

Cardiomyopathy is an important cause of chronic disability and death in pediatric patients and currently accounts for approximately 50% of cardiac transplants performed during childhood. Left ventricular (LV) size and function are important independent predictors of outcome, and echocardiography is the primary way to assess ventricular function in children. Although there is extensive experience with this technology, data are limited on how ventricular function changes over time in children, which is a major impediment to conducting controlled trials of therapy in children.

This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children's Hospital Boston, Boston, MA

Columbia College of Physicians and Surgeons, New York, NY

Children's Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Primary Children's Medical Center, Salt Lake City, UT

Washington University, St. Louis, MO

DESIGN NARRATIVE:

This observational study will prospectively evaluate pediatric patients with dilated cardiomyopathy who are undergoing clinically indicated echocardiographic evaluation of LV function. Patients who undergo at least two echocardiograms 3 to 18 months apart will have their studies performed by the same ultrasonographer. All studies will be sent to the core laboratory for evaluation of variability in LV mass, volume, and ejection fraction.

  Eligibility

Ages Eligible for Study:   up to 22 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients up to 22 years of age with dilated cardiomyopathy followed at participating clinical centers or newly diagnosed during the recruitment period

Criteria

Inclusion Criteria:

  • Less than 22 years of age
  • Any race
  • Diagnosis of dilated cardiomyopathy
  • LV and diastolic diameter greater than 5.5 cm (or z-score for BSA greater than 2) on the primary image acquisition from the first study echocardiogram
  • LV ejection fraction less than 50% (or z-score for age less than -2) or shortening fraction less than 28% (or z-score for age less than -2) as measured on the primary image acquisition from the first study echocardiogram
  • Disease onset greater than 2 months prior to screening
  • Anticipated to undergo repeat evaluation at the same institution at least 3 months but not more than 13 months later
  • Informed consent of parent(s) or legal guardian and assent of subject if required

Exclusion Criteria:

  • Hypertrophic cardiomyopathy
  • Restrictive cardiomyopathy
  • Myocardial noncompaction (LV hypertrabeculation); patient is eligible for the study as long as the echocardiogram performed at the time of screening has no evidence of myocardial noncompaction
  • Ventricular paced rhythm
  • Atrial or ventricular ectopy at ratio greater than 1:4
  • Suspected acute myocarditis
  • Tachycardia-induced cardiomyopathy
  • Congenital heart disease (repaired or unrepaired)
  • Currently on intravenous inotropic support
  • Current left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO)
  • Heart transplant waiting list status of 1A or 1B
  • Co-morbid condition that precludes the ability to successfully obtain an echocardiogram according to the specifications of the study protocol
  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: NCT00123071

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
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
New England Research Institutes
Pediatric Heart Network
Investigators
Principal Investigator: Lynn Sleeper, ScD New England Research Institutes
  More Information

No publications provided by New England Research Institutes

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00123071     History of Changes
Other Study ID Numbers: 236, U01HL068292, U01HL068290, U01HL068288, U01HL068285, U01HL068281, U01HL068279, U01HL068270, U01 HL068270, U01 HL068279, U01 HL068281, U01 HL068285, U01 HL068288, U01 HL068290, U01 HL068292, U42 HL068269
Study First Received: July 20, 2005
Last Updated: January 24, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 19, 2014