Hypertension Clinical Trial
To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic factors over a follow-up period of two to three years.
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.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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