Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041431
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2002-07-08
Brief Title:
Estrogen Cytokines and Heart Failure in Women
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:
2005-05
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 determine the effects of estrogen therapy on postmenopausal women with congestive heart failure
Detailed Description:
BACKGROUND
Congestive heart failure CHF is a leading cause of morbidity mortality and hospitalization in women The increase in mortality suggests that postmenopausal estrogen loss may alter the phenotypic expression of CHF Because estrogen is a potent in vitro inhibitor of pro-inflammatory cytokines eg TNFa IL-1B IL-6 which are re-expressed by the failing myocardium in patients with CHF and are related to an adverse prognosis the study postulates that estrogen replacement will improve the outcome of postmenopausal women with CHF
DESIGN NARRATIVE
The randomized double blind study was conducted in 166 postmenopausal women with congestive heart failure due to idiopathic ienonischemic dilated cardiomyopathy and NYHA class II or III symptoms on either combined estrogen and progestin or placebo Women maintained their then current congestive heart failure medications for six months Three outcomes were measured 1 Congestive heart failure severityfunctional capacity quantified by maximum oxygen consumption during metabolic stress testing 2 Left and right ventricular remodeling quantified by electron bean CT scan 3 quality of life assessment by the Minnesota Living with Heart Failure and Kansas City cardiomyopathy questionnaires In addition measurements were made of pro-inflammatory markers that had been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduced them
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Congestive heart failure CHF is a leading cause of morbidity mortality and hospitalization in women The increase in mortality suggests that postmenopausal estrogen loss may alter the phenotypic expression of CHF Because estrogen is a potent in vitro inhibitor of pro-inflammatory cytokines eg TNFa IL-1B IL-6 which are re-expressed by the failing myocardium in patients with CHF and are related to an adverse prognosis the study postulates that estrogen replacement will improve the outcome of postmenopausal women with CHF
DESIGN NARRATIVE
The randomized double blind study was conducted in 166 postmenopausal women with congestive heart failure due to idiopathic ienonischemic dilated cardiomyopathy and NYHA class II or III symptoms on either combined estrogen and progestin or placebo Women maintained their then current congestive heart failure medications for six months Three outcomes were measured 1 Congestive heart failure severityfunctional capacity quantified by maximum oxygen consumption during metabolic stress testing 2 Left and right ventricular remodeling quantified by electron bean CT scan 3 quality of life assessment by the Minnesota Living with Heart Failure and Kansas City cardiomyopathy questionnaires In addition measurements were made of pro-inflammatory markers that had been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduced them
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 |
|---|---|---|---|
| R01HL068939 | NIH | None | httpsreporternihgovquickSearchR01HL068939 |