Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005262
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2000-05-25
Brief Title:
Epidemiology of Idiopathic Dilated Cardiomyopathy Washington DC Dilated Cardiomyopathy Study
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To identify risk factors for idiopathic dilated cardiomyopathy and to examine prognostic factors over a follow-up period of two to three years
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 10000 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 DC Dilated Cardiomyopathy Study Dr Coughlin started his research at Georgetown University in Washington DC 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
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 10000 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 DC Dilated Cardiomyopathy Study Dr Coughlin started his research at Georgetown University in Washington DC 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R29HL044904 | NIH | None | httpsreporternihgovquickSearchR29HL044904 |