Heart and Estrogen-Progestin Replacement Study (HERS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether hormone replacement therapy in post menopausal women with coronary artery disease prevents future heart attacks or death from coronary heart disease.

Detailed Description
-----------------
A randomized, blinded trial in post menopausal women with cornaornary artery disease to test the hypothesis, among 2340 women who have a uterus, that those randomized to receive estrogen-progestin replacement therapy (Premanrin .625 mg daily plus medroxygrprogesterone acetate 2.5 mg daily) have the same frequency on new CHD events (myocardial infarction and CHD death) as those randomized to placebo.

Official Title
-----------------
Heart and Estrogen-Progestin Replacement Study (HERS)

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: <75 y.o. uterus present postmenopausal evidence of CHD signed consent Exclusion Criteria: MI, CABG, mechanical revascularization within 6 months serum triglyceride >300mg/dl used hormone therapy or estrogen vaginal cream in past 3 months history of DVT or pulmonary embolism history of breast cancer or mammogram suggestive of cancer history of endometrial cancer abnormal uterine bleeding pap smear abnormal SGOT more than 1.2 times normal Disease judged to be fatal within 4 yrs alcoholism, drug abuse NYHA Class IV congestive heart failure uncontrolled hypertension uncontrolled diabetes participation in any other investigational study

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Premarin .625 mg daily plus medroxyprogesterone 2.5 mg daily|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial Infarction |  |  | 
| CHD Death |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CABG, revascularization, angina |  |  | 
| serum lipids |  |  | 
| quality of life |  |  | 
| compliance |  |  | 
| incidence of uterine bleeding and endometrial hyperplasia |  |  | 
| incidencet and severity of vasomotor and genitourinary symptoms |  |  | 
| adverse effects |  |  | 
| thromboembolic events |  |  | 
| symptomatic gallbladder disease |  |  | 
| fractures |  |  | 
| cancer |  |  | 
| stroke |  |  | 
| peripheral arterial disease |  |  | 
| total mortality |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Heart Disease, Hormone replacement therapy, Estrogen, Postmenopausal women