Cardiovascular Diseases Clinical Trial
To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.
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 (e.g., 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 (i.e.nonischemic) 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 severity/functional 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.
;
Allocation: Randomized, Masking: Double-Blind
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