New study to see whether a skin cream can prevent heart failure in women

Women’s health expert Prof Susan Davis has been awarded a $160,000 Heart Foundation Vanguard Grant, and along with it their prestigious Ross Hohenen Award for Innovation, for a new study to evaluate the efficacy of testosterone supplementation in preventing a specific type of heart disease in post-menopausal women.

Heart failure with preserved ejection fraction (HFpEF) is an emerging global health problem accounting for approximately half of all patients with heart failure.  It’s three times more common in women than in men, and a large age-associated spike in prevalence – approximately 4-fold - is seen in women aged 55-64 years, when their blood testosterone concentrations are at their lowest.

The new study – called ETHEL – builds on Prof Davis’s impressive track record expanding medical knowledge around the roles of sex hormones, including testosterone, on the physical and mental health of menopausal and post-menopausal women.

She’ll work with Dr Rakibul Islam from her own team at the Women’s Health Research Program at the Monash School of Public Health and Preventive Medicine, and Prof Thomas Marwick and Dr Erin Howden from the Baker Heart and Diabetes Institute, who have specific expertise in HFpEF diagnosis and monitoring.

Prof Davis says, “Sex hormone changes during menopause can have debilitating symptoms on some women, and may have serious implications for long-term heart health. Half of earth’s inhabitants are women – this type of research therefore has the scope for massive impact.”

There is already evidence from animal models that low testosterone is associated with the development of HFpEF, and research including some of Prof Davis’s previous studies provides biological plausibility and preliminary clinical evidence of the role of testosterone insufficiency in progression to HFpER in post-menopausal women.

The Therapeutic Goods Administration has recently approved a testosterone skin cream for post- menopausal women experiencing sexual dysfunction, which has been shown to have no negative impacts on heart health. Prof Davis and the ETHEL team will conduct a randomized controlled pilot trial to measure the impacts of the skin cream on well-established indicators of heart function in women with asymptomatic heart failure.

If the findings are positive, this would justify larger, longer-term studies that could one day lead to changes in medical practice and massive reductions in disease burden and healthcare costs.

The women taking part in the study will be drawn from a pre-existing Baker Heart and Diabetes Institute study, VicELF, in which 52 per cent of participants are known to fit ETHEL inclusion criteria.

Prof Davis says, “The ETHEL team is proud to be making this contribution to women’s health, and thrilled that the study design and potential impact has been recognized by the Heart Foundation with the Ross Hohenen Award.

“It’s such important knowledge for us to have, and we thank the Heart Foundation’s many donors who make this and other heart-related research projects possible.”

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Monash University is Australia’s largest university with more than 80,000 students. In the 60 years since its foundation, it has developed a reputation for world-leading high-impact research, quality teaching, and inspiring innovation.

With four campuses in Australia and a presence in Malaysia, China, India, Indonesia and Italy, it is one of the most internationalised Australian universities.

As a leading international medical research university with the largest medical faculty in Australia and integration with leading Australian teaching hospitals, we consistently rank in the top 50 universities worldwide for clinical, pre-clinical and health sciences.

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