Evaluating Testosterone Therapy to Prevent Heart Failure in Women: The ETHEL study.

Phase 4

• Conditions: Stage B heart failure with preserved ejection fraction; Reproductive Health and Childbirth - Menstruation and menopause; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12623000165684
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-17
• Last Update Posted: 27 February 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 38

Inclusion Criteria

Evidence of Stage B heart failure with reduced functional capacity (<85% age-predicted VO2peak).
- Normal mammogram within the preceding 2 years

Exclusion Criteria

- Heart failure, either documented or undiagnosed with an EF <40% or NTproBNP >400ng/L
- Other cardiac disease (myocardial infarction, angina; known coronary artery disease; valve disease more than moderate)
- Features incompatible with the study design (unlikely to be adherent to follow-up; <12 months life expectancy due to concomitant disease; participation in another clinical trial where blinded treatment would be unacceptable; unable to provide written informed consent)
- Inability to acquire interpretable echo images (uncommon)
- Unstable diabetes (HbA1C>7.5%)
- Estrogen-sensitive cancer
- Use of any drugs or dietary supplements that may affect testosterone effects including, but not limited to systemic antiandrogen therapy (spironolactone; cyproterone acetate; finasteride; minoxidil)
- Treatment with SGLT-2 inhibitors or GLP-1 agonists as indicated
- Recent use of androgen therapy
- Contraindication to exercise
- Inability to speak or understand English

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be any change in cardiorespiratory fitness, assessed by change in VO2peak during cardiopulmonary exercise testing (CPET) on a cycle ergometer.[Change will be measured at 4 months post randomisation (at the conclusion of first treatment phase). It will then be measured both before and after the second phase of treatment (i.e. at 5 and 9 months post randomisation).]