None listed
Conditions
Brief summary
This proof-of-concept randomised double-blind placebo-controlled crossover study will determine the effects of transdermal testosterone supplementation in post-menopausal females with stage B heart failure with preserved ejection fraction (HFpEF) on attenuation of heart failure risk. We seek to do this based on the previously demonstrated efficacy of this approach in female patients with chronic HF as our epidemiological evidence that suggests low testosterone in females is associated with increased risk of major cardiovascular events and there is an urgent need to identify effective prevention and treatment strategies for the patients with HFpEF. Our hypothesis is that transdermal testosterone, versus placebo, will result in a clinically meaningful improvement in V02peak, which is a strong prognostic indicator for future HF risk in postmenopausal women with stage B HFpEF. The improvement will be due to improvements in central cardiac function and structure. The study will provide high-quality evidence as to whether testosterone, as a novel intervention, will improve cardiorespiratory fitness in women at risk of HFpEF, and therefore whether testosterone therapy has the potential and feasibility as a treatment for this condition, for which there is currently no known treatment.
Interventions
This is a randomised double-blind placebo-controlled crossover study. Participants will receive either treatment or placebo for 4 months, then receive the alternative study drug for 4 months with a 4-week washout period in between each 4-month treatment cycle. The total duration of participation in this study is 9 months.
Application of active treatment, 1% testosterone cream, 0.5ml (10mg/ml), or placebo cream
applied transdermally daily to upper thigh or buttock by participant for 4 months.
Co
This is a randomised double-blind placebo-controlled crossover study. Participants will receive either treatment or placebo for 4 months, then receive the alternative study drug for 4 months with a 4-week washout period in between each 4-month treatment cycle. The total duration of participation in this study is 9 months. Application of active treatment, 1% testosterone cream, 0.5ml (10mg/ml), or placebo cream applied transdermally daily to upper thigh or buttock by participant for 4 months. Compliance will be assessed by collection and weighing of returned cream containers at end of treatment period.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed