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Heart Diseases |
Cardiac Arrest; Cardiac Diseases; Endocarditis; Heart Disease; Heart Disease and the Mind-Body Constitution; Heart Disease, Congenital; Heart Diseases (General); Heart Diseases--Prevention; Heart Infection, Endocarditis |
Clinical Trial: Pediatric Cardiomyopathy Registry
This study is no longer recruiting patients.
Purpose
To establish and maintain a national registry of children with different forms of cardiomyopathy.
| Condition |
|---|
| Cardiovascular Diseases Heart Diseases Myocardial Diseases |
MedlinePlus related topics: Cardiomyopathy; Heart Diseases; Heart Diseases--Prevention; Vascular Diseases
Study Type: Observational
Study Design: Screening
Study start: September 1995; Study completion: August 2005
BACKGROUND: Children with cardiomyopathy represent the most dismal outcome of any group of diseases followed by pediatric cardiologists, with up to 40 percent of infants and children with symptomatic cardiomyopathy failing medical or surgical management in the first year following diagnosis. For 57 percent of children with cardiomyopathy, no etiology is known. Although pediatric cardiomyopathy is common, there is considerable variation in its causes. Therefore, for any specific etiology, no center of pediatric cardiology sees a sufficient number of patients to make major advances in understanding this group of diseases. The registry was developed to collect and organize all relevant data on the condition. Data accrued by and reported by the registry should lead to increased awareness and knowledge of pediatric cardiomyopathy and its causes, as well as the development of new diagnostic and therapeutic approaches.
DESIGN NARRATIVE: The registry consists of a prospective, population-based cohort of patients in New England and the Central Southwestern United States and a retrospective cohort of patients diagnosed between 1991 and 1996. Annual follow-up data are collected on all patients.
Specific hypotheses are that l) during the period of the registry, the percentage of cases that are diagnosed as idiopathic will decrease (i.e., etiologies will be found) and 2) at the time of diagnosis of cardiomyopathy, factors such as gender, ethnicity, age, type of cardiomyopathy, and presence or absence of a syndrome can help predict outcomes. Definition of entry and exclusion criteria, clinical quality assurance, and accrual and retention of participating clinical centers are largely under the direction of the University of Rochester in Rochester, New York and Baylor College of Medicine. Virtually all pediatric cardiology centers in the United States, Puerto Rico, and Canada have expressed their willingness to send patient information to such a registry. The study has been extended through August, 2004.
Eligibility
Ages Eligible for Study: up to 18 Years, Genders Eligible for Study: Both
Criteria
Location Information
Steven Lipshultz, University of Miami
More Information
Publications
Grenier MA, Osganian SK, Cox GF, Towbin JA, Colan SD, Lurie PR, Sleeper LA, Orav EJ, Lipshultz SE. Design and implementation of the North American Pediatric Cardiomyopathy Registry. Am Heart J. 2000 Feb;139(2 Pt 3):S86-95.
Bowles KR, Zintz C, Abraham SE, Brandon L, Bowles NE, Towbin JA. Genomic characterization of the human peptidyl-prolyl-cis-trans-isomerase, mitochondrial precursor gene: assessment of its role in familial dilated cardiomyopathy. Hum Genet. 1999 Dec;105(6):582-6.
Lipshultz SE, Fisher SD, Lai WW, Miller TL. Cardiovascular monitoring and therapy for HIV-infected patients. Ann N Y Acad Sci. 2001 Nov;946:236-73. Review.
Lipshultz SE, Sleeper LA, Towbin JA, Lowe AM, Orav EJ, Cox GF, Lurie PR, McCoy KL, McDonald MA, Messere JE, Colan SD. The incidence of pediatric cardiomyopathy in two regions of the United States. N Engl J Med. 2003 Apr 24;348(17):1647-55.
Benun J, Fisher SD, Orav EJ, Schwartz ML, Exil V, Messere C, Lipshultz SE. Cardiac management by pediatricians versus pediatric cardiologists in an inpatient academic center. Am Heart J. 2003 Mar;145(3):424-9.
Lipshultz SE, Lipsitz SR, Sallan SE, Simbre VC 2nd, Shaikh SL, Mone SM, Gelber RD, Colan SD. Long-term enalapril therapy for left ventricular dysfunction in doxorubicin-treated survivors of childhood cancer. J Clin Oncol. 2002 Dec 1;20(23):4517-22.
Bergmann SR, Herrero P, Sciacca R, Hartman JJ, Rubin PJ, Hickey KT, Epstein S, Kelly DP. Characterization of altered myocardial fatty acid metabolism in patients with inherited cardiomyopathy. J Inherit Metab Dis. 2001 Nov;24(6):657-74.
Lipshultz SE, Rifai N, Dalton VM, Levy DE, Silverman LB, Lipsitz SR, Colan SD, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Gelber RD, Sallan SE. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med. 2004 Jul 8;351(2):145-53.
Mone SM, Gillman MW, Miller TL, Herman EH, Lipshultz SE. Effects of environmental exposures on the cardiovascular system: prenatal period through adolescence. Pediatrics. 2004 Apr;113(4 Suppl):1058-69. Review.
Adams MJ, Lipsitz SR, Colan SD, Tarbell NJ, Treves ST, Diller L, Greenbaum N, Mauch P, Lipshultz SE. Cardiovascular status in long-term survivors of Hodgkin's disease treated with chest radiotherapy. J Clin Oncol. 2004 Aug 1;22(15):3139-48.
Record last reviewed: February 2005
Last Updated: February 17, 2005
Record first received: May 25, 2000
ClinicalTrials.gov Identifier: NCT00005391
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
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