Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection

This study is currently recruiting patients.

Sponsored by

National Heart, Lung, and Blood Institute (NHLBI) 

Purpose

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.

Study Type: Clinical Trial

Official Title: Immunomodulatory Effects of Hormone Therapy in Postmenopausal Women With Chronic Chlamydia Pneumoniae or Cytomegalovirus Infection

Further Study Details: 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.  

Eligibility

Genders Eligible for Study:  Female Criteria

Must be a postmenopausal woman 65 years of age or younger.

Time since last date of menses should be at least 12 months, with plasma estradiol less than 50 pg/ml and FSH greater than 50 pg/ml.

Women must be without clinical evidence of CAD as determined by history, cardiovascular physical examination, and EKG.

Must not have used hormone replacement therapy within past 6 months.

Must not have used dietary supplements and any medication (over-the-counter or prescribed) within 1 month. Acetaminophen use is allowed.

Must not have a history of alcoholism or binge-drinking.

Must not have diabetes mellitus or known abnormal glucose intolerance test.

Must not have a history of stroke, angina or myocardial infarction.

Must not have a history of deep venous thrombosis/pulmonary embolism.

Must not have a history of cancer (except for treated squamous cell and basal cell carcinomas).

Must not have evidence of liver disease (liver function enzymes greater than twice the upper limit of normal).

Must not have impaired renal function (creatinine greater than 1.6 mg/dl).

Must not have a diagnosis of an autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, thyroiditis, Raynaud's Disease).

Must not have a history of intermittent vaginal bleeding.

Must not have serum triglycerides greater than 400 mg/dL.

Location and Contact Information

Maryland

National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike   Bethesda,   Maryland,    20892,   United States; Recruiting

PRPL     Warren G. Magnuson Clinical Center National Institutes of Health   Bethesda,    Maryland,   20892-4754,   United States  1-800-411-1222    prpl@mail.cc.nih.gov  

More Information

Detailed Web Page

Publications that lead up to this study

Ross. 1993. The pathogenesis of atherosclerosis: a perspective for the 1990s, Nature, Vol. 362, p. 801

Danesh. 1997. Chronic infections and coronary heart disease: is there a link?, Lancet, Vol. 350, p. 430

Gaydos. 1996. Replication of Chlamydia pneumoniae in vitro in human macrophages, endothelial cells, and aortic artery smooth muscle cells, Infect Immun, Vol. 64, p. 1614

Study ID Numbers  99-H-0100

NLM Identifier  NCT00001890

Date study started May 7, 1999

Recruitment status verified  May 2, 2000

Last Updated  May 2, 2000

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