Evaluating Testosterone Therapy to Prevent Early Heart Failure in Women: The ETHEL study
RECRUITMENT NOW COMPLETED
A randomised controlled trial evaluating whether testosterone therapy can prevent early changes in the heart from progressing to heart failure in postmenopausal women. This study is being conducted in conjunction with the Baker Heart and Diabetes Institute and supported by a National Heart Foundation Vanguard Grant.
Background
Heart failure is common in women over 55 years who have diabetes, high blood pressure and obesity. Changes in the structure and function of the heart can develop without women knowing they are occurring. If these early changes are left unchecked, progression to symptomatic heart failure is likely. This is a serious condition.
Testosterone is a hormone that is key to women’s health. Testosterone levels peak when women are in their early 20s, then gradually decline to reach their lowest point after menopause when women are in their 60s. This coincides with a 4-fold increase in the number of women who develop heart failure.
There are presently no therapies to prevent early changes in the heart from progressing to symptomatic heart failure.
Why are we doing this research?
The ETHEL study aims to investigate whether supplementing testosterone in postmenopausal women to levels similar to that of premenopausal women may prevent progression of early heart changes to heart failure.
This study will determine if testosterone therapy will improve exercise tolerance, heart muscle appearance and function, and quality of life.
Who can participate?
We are seeking women aged 55 years and older who have risk factors for heart failure such as obesity, hypertension and diabetes.
A screening echocardiogram (heart ultrasound) will be provided for women who meet these eligibility criteria.
What does the study involve?
All study participants will use a testosterone cream (approved and safe for use in women) for 4 months and an identical placebo cream for 4 months in random order.
There will be 5 study visits that involve exercise testing, echocardiography, and blood collection.
Study visits will be conducted at the Baker Institute, located at the Alfred Hospital or HeartWest Hoppers Crossing.
Recruitment for this study is now completed. For further information about the study, please contact us:
Women’s Health Research Program
Monash University
Phone: +61 3 9903 0836
Email: womens.health@monash.edu
This study is approved by the Monash University Human Research Ethics Committee