To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.
Official Title
Conditions
– Cardiovascular Diseases- Heart Failure, Congestive- Heart Diseases- Menopause
Study Type
Interventional
Study Design
Randomized, Double-Blind, Placebo Control
Further Details
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 is 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 will maintain their current congestive heart failure medications for six months. Three outcomes will be 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 will be made of pro-inflammatory markers, that have been demonstrated to be elevated in congestive heart failure to assess whether hormone replacement therapy reduces them.
Study Start
Eligibility & Criteria
Genders Eligible for Study: Female Criteria Postmenopausal women with NYHA Class II or Class III congestive heart failure due to idiopathic dilated cardiomyopathy.
Total Enrolment
Contact Details
Location Information :Study chairs or principal investigators [1] Steven Reis, University of Pittsburgh
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