Estrogen, Cytokines and Heart Failure in Women

National Institutes of Health (NIH)

Status: Completed

Conditions: Menopause; Heart Failure, Congestive; Cardiovascular Diseases; Heart Diseases

Treatments: Drug: Hormone Replacement Therapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00041431

R01HL068939 (U.S. NIH Grant/Contract)

1181

Details and patient eligibility

About

To determine the effects of estrogen therapy on postmenopausal women with congestive heart failure.

Full 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 (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.

Sex: Female

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Postmenopausal women with NYHA Class II or Class III congestive heart failure due to idiopathic dilated cardiomyopathy.