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

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.