Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
Women's Estrogen/Progestin Lipid Lowering Hormone Atherosclerosis Regression Trial (WELL-HART)
To determine the effects, in postmenopausal women, of hormone replacement therapy on
 progression/regression of coronary heart disease, as measured by quantitative angiography.
BACKGROUND:

 The trial was a logical extension of preceding observational and cross-sectional studies on
 estrogen replacement therapy. Overall, the studies suggested 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 had been prone to a number of biases. One major criticism of
 observational studies had been that women receiving estrogen were generally healthier and
 more compliant than non-estrogen users.

 There was a very large body of observational data suggesting that the use of estrogen in
 postmenopausal women reduced coronary heart disease mortality by approximately 45 percent. At
 the same time, there had been some concern that replacement therapy increased the likelihood
 of uterine cancer and perhaps breast cancer as well, although it was generally accepted that
 this risk was probably significantly less than the benefits obtained from the reduction of
 coronary heart disease mortality.

 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.

 The study completion date listed in this record was obtained from the "Completed Date"
 entered in the Query View Report System (QVR).
Postmenopausal women with angiographically-documented coronary disease. Approximately 70
 percent minority