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.
Status | Completed |
Enrollment | 80 |
Est. completion date | March 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Heart, Lung and Blood Institute (NHLBI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Danesh J, Collins R, Peto R. Chronic infections and coronary heart disease: is there a link? Lancet. 1997 Aug 9;350(9075):430-6. Review. — View Citation
Gaydos CA, Summersgill JT, Sahney NN, Ramirez JA, Quinn TC. Replication of Chlamydia pneumoniae in vitro in human macrophages, endothelial cells, and aortic artery smooth muscle cells. Infect Immun. 1996 May;64(5):1614-20. — View Citation
Ross R. The pathogenesis of atherosclerosis: a perspective for the 1990s. Nature. 1993 Apr 29;362(6423):801-9. Review. — View Citation
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