NCT00123071

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
2 countries

8 active sites

Status
completed

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

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

3.4 years

First QC Date

July 20, 2005

Last Update Submit

January 24, 2013

Conditions

Cardiomyopathy, Dilated

Outcome Measures

Primary Outcomes (1)

  • Inter-study variability of echo measurements; variance at a single point in time and variance of change in measurements over time

    Measured for up to 18 months

Secondary Outcomes (3)

  • Relative magnitude of the various sources of variability in echocardiographic outcomes in order to optimize operational procedures that can minimize variance

    Measured for up to 18 months

  • 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

    Measured for up to 18 months

  • Relationship of clinical status, including treatment, to the interstudy variability and repeatability of echocardiographic measurements.

    Measured for up to 18 months

Eligibility Criteria

AgeUp to 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Washington University

St Louis, Missouri, 63110, 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 (4)

  • Selamet Tierney ES, Hollenbeck-Pringle D, Lee CK, Altmann K, Dunbar-Masterson C, Golding F, Lu M, Miller SG, Molina K, Natarajan S, Taylor CL, Trachtenberg F, Colan SD; Pediatric Heart Network Investigators. Reproducibility of Left Ventricular Dimension Versus Area Versus Volume Measurements in Pediatric Patients With Dilated Cardiomyopathy. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006007. doi: 10.1161/CIRCIMAGING.116.006007.

    PMID: 29133477DERIVED

  • Lee CK, Margossian R, Sleeper LA, Canter CE, Chen S, Tani LY, Shirali G, Szwast A, Tierney ES, Campbell MJ, Golding F, Wang Y, Altmann K, Colan SD; Pediatric Heart Network Investigators. Variability of M-mode versus two-dimensional echocardiography measurements in children with dilated cardiomyopathy. Pediatr Cardiol. 2014 Apr;35(4):658-67. doi: 10.1007/s00246-013-0835-9. Epub 2013 Nov 22.

    PMID: 24265000DERIVED

  • Molina KM, Shrader P, Colan SD, Mital S, Margossian R, Sleeper LA, Shirali G, Barker P, Canter CE, Altmann K, Radojewski E, Tierney ES, Rychik J, Tani LY; Pediatric Heart Network Investigators. Predictors of disease progression in pediatric dilated cardiomyopathy. Circ Heart Fail. 2013 Nov;6(6):1214-22. doi: 10.1161/CIRCHEARTFAILURE.113.000125. Epub 2013 Oct 16.

    PMID: 24132734DERIVED

  • Colan SD, Shirali G, Margossian R, Gallagher D, Altmann K, Canter C, Chen S, Golding F, Radojewski E, Camitta M, Carboni M, Rychik J, Stylianou M, Tani LY, Selamet Tierney ES, Wang Y, Sleeper LA; Pediatric Heart Network Investigators. The ventricular volume variability study of the Pediatric Heart Network: study design and impact of beat averaging and variable type on the reproducibility of echocardiographic measurements in children with chronic dilated cardiomyopathy. J Am Soc Echocardiogr. 2012 Aug;25(8):842-854.e6. doi: 10.1016/j.echo.2012.05.004. Epub 2012 Jun 5.

    PMID: 22677278DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lynn Sleeper, ScD

    Carelon Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2005

First Posted

July 22, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2008

Study Completion

June 1, 2009

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

CA(1)US(7)