Atherosclerosis Clinical Trial
Official title:
Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection
Hardening of the arteries (atherosclerosis) and heart disease are much more common in men
than in women. However, as women grow older, especially after menopause the incidence of
atherosclerosis and heart disease increases. These findings suggest that estrogen may be
protective and help in preventing heart disease.
Studies of large groups of post-menopausal women suggest that hormone replacement therapy
(therapy that includes estrogen) reduces the risk of heart disease. Estrogen causes
favorable changes in particles that carry cholesterol in the blood stream and improves
function of blood vessels. Estrogen may also stimulate the immune system's ability to fight
off infections that may lead to or contribute to atherosclerosis.
Researchers believe two specific infectious agents (Chlamydia pneumoniae and human
cytomegalovirus) may cause damage to the lining of blood vessels resulting in inflammation
and the development of atherosclerosis.
The purpose of this study is to determine if estrogen treatment can change how the immune
system responds to chronic infections, by Chlamydia pneumoniae and human cytomegalovirus, in
postmenopausal women.
The incidence of atherosclerotic cardiovascular disease in women does not approach rates seen in men until approximately a decade following menopause, suggesting that estrogen is vasculoprotective. Infectious pathogens such a Chlamydia pneumoniae (C. pneumoniae) and human cytomegalovirus (hCMV) have been implicated in the pathogenesis of atherosclerosis. Experimental studies in cultured lymphocytes and animals suggest that estrogen stimulates cell-mediated immune responsiveness, observations that are potentially relevant to the eradication of intracellular pathogens including C. pneumoniae and hCMV. The purpose of this study is to determine whether estrogen therapy augments cell-mediated immune responsiveness in estrogen-deficient postmenopausal women who have serologic evidence of chronic infection with C. pneumoniae and/or hCMV. A comparison will be made between seropositive and seronegative women. We propose that estrogen therapy will stimulate a more efficient cell-mediated response to these chronically persistent infectious intracellular pathogens, resulting in eradication of these organisms that are of potential importance in atherogenesis. ;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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