Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Epidemiology of Idiopathic Dilated Cardiomyopathy (Washington, DC Dilated Cardiomyopathy Study)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005262
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: May 2000
  Purpose

To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic factors over a follow-up period of two to three years.


Condition
Cardiovascular Diseases
Heart Diseases
Myocardial Diseases
Asthma
Diabetes Mellitus
Hypertension

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1990
Estimated Study Completion Date: June 1996
Detailed Description:

BACKGROUND:

Idiopathic dilated cardiomyopathy is an often fatal cause of heart failure in young adults which is characterized by dilatation of the ventricles, increased myocardial mass, and impairment of systolic function. Dilated cardiomyopathy is more common than hypertrophic and restrictive cardiomyopathy, and the symptoms and physical signs are those of left-sided and eventually right-sided heart failure. Histologic findings in the condition include nonspecific interstitial myocardial fibrosis and myocyte hypertrophy. Despite the large number of systemic or generalized disease processes which have been associated with secondary dilated cardiomyopathy, the majority of cases are idiopathic. Mortality rates from cardiomyopathy have increased dramatically since 1970, and in 1990 over 10,000 deaths annually were attributed to cardiomyopathy in the United States.

DESIGN NARRATIVE:

The study had a prospective case-control design. Medical records of possible cases of idiopathic dilated cardiomyopathy who were discharged from five Washington, D. C. acute care hospitals over a two year period were abstracted so that standard diagnostic criteria could be applied. Two neighborhood controls were identified for each case. Cases and controls were matched on five year age intervals, sex, and telephone exchange. Cases were contacted annually during the two to three year follow-up period to determine vital status. The study determined whether the reported association between idiopathic dilated cardiomyopathy and asthma could be confirmed and the possible role of asthma medications, cigarette smoking, moderate alcohol consumption, and diabetes mellitus in the etiology of idiopathic dilated cardiomyopathy. The role of hypertension was also studied.. Statistical analysis consisted of case-control comparisons using conditional logistic regression techniques, and survival analyses using Kaplan-Meier curves and proportional hazards models.

The study was also known as the Washington, D.C. Dilated Cardiomyopathy Study. Dr. Coughlin started his research at Georgetown University in Washington, D.C. and transferred to Tulane University.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  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.

No Contacts or Locations Provided
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005262     History of Changes
Other Study ID Numbers: 1146
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Cardiovascular Diseases
Diabetes Mellitus
Heart Diseases
Hypertension
Cardiomegaly
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014