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Home > "W" Clinical Trials Conditions > Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)  Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
For Condition: Cardiovascular Diseases,Coronary Disease,Heart Diseases,Myocardial Ischemia,Postmenopause
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the effects, in postmenopausal women, of hormone replacement therapy on progression/regression of coronary heart disease, as measured by quantitative angiography.
Details: BACKGROUND: The trial is a logical extension of preceding observational and cross-sectional studies on estrogen replacement therapy. Overall, the studies suggest a 50 percent reduction in risk of coronary heart disease in current estrogen users compared to non-users. In spite of such striking findings, most studies have been prone to a number of biases. One major criticism of observational studies has been that women receiving estrogen are generally healthier and more compliant than non-estrogen users. There is a very large body of observational data suggesting that the use of estrogen in postmenopausal women reduces coronary heart disease mortality by approximately 45 percent. At the same time, there has been some concern that replacement therapy increases the likelihood of uterine cancer and perhaps breast cancer as well, although it is generally accepted that this risk is probably significantly less than the benefits obtained from the reduction of coronary heart disease mortality. The Women's Health Initiative will provide outcome data for cardiovascular and cancer event rates for both unopposed estrogen and cyclical progestin opposed estrogen, but will not provide insight into mechanisms of treatment effect, with direct assessment of coronary and carotid atherosclerosis. DESIGN NARRATIVE: Randomized, double-blind, placebo-controlled. After baseline angiograms, patients were randomized to one of three arms: micronized 17-beta estradiol, 1 milligram per day; 17-beta estradiol plus medroxyprogesterone, 5 milligrams per day for twelve days per month; and placebo. Subjects in all three arms received lipid-lowering therapy, low fat/low cholesterol diet, and the HMG-CoA reductase inhibitor, pravastatin, in sufficient dosage to reduce low density lipoprotein (LDL) cholesterol levels below 130 mg/dl. The primary endpoint was progression/regression of coronary obstructive disease as measured by angiography, including the expert human panel and quantitative computer analysis. The secondary endpoint was carotid media-intima thickness determined by ultrasound. Clinical measures included lipids, lipoproteins, apolipoproteins, estradiol and medroxyprogesterone levels, urinary prostanoid metabolites, and insulin/glucose metabolism. Subjects were recruited at three centers with active coronary angiography units. Several core facilities supported the study: a Core Lipid Lab, a Reproductive Endocrine Lab, the Biostatistics Lab (Data Coordinating Center) and the Angiographic Imaging Laboratory.
Eligibility:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 45 Years/75 Years
Genders: Female
Protocol Entry Criteria: Postmenopausal women with angiographically-documented coronary disease. Approximately 70 percent minority
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardHodis, , University of Southern California
Additional Information:
Study ID Numbers: 103;
Study Start Date: March 1995
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000559
Other Postmenopause Studies:
1. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
2. Epidemiological Tool To Detect Angina Pectoris in Blacks
3. Genetic Determinants:Low HDL, High Triglycerides, Obesity
4. Prospective Assessment After Pediatric Cardiac Ablation (PAPCA)
5. Myocardial Infarction Triage and Intervention Project (MITI)
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Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
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