A clinical trial funded by a global health research initiative will investigate a combination of hormone therapy and exercise training as a potential treatment for coronary microvascular dysfunction (CMD), a condition that primarily affects women. The trial, known as RESTORE, is led by researchers at UNSW Sydney and supported by Wellcome Leap.
Background on CMD
Coronary microvascular dysfunction (CMD) is a disorder of the heart's small blood vessels. According to the researchers, the condition is not detectable on standard angiograms, which are designed to identify blockages in the heart's larger arteries.
- The condition is reported to be more common in women, particularly those who are post-menopausal.
- Researchers state that up to 70% of women presenting with chest pain who undergo angiography are told their arteries are clear, yet many continue to experience symptoms such as angina (chest pain), breathlessness, and fatigue.
- Data cited by the researchers indicates that CMD carries up to a four-fold higher risk of major cardiovascular events.
- Currently, no treatments target the underlying biology of CMD.
The RESTORE Trial
The RESTORE trial will test the efficacy of transdermal oestrogen and structured exercise training as a combined or individual treatment for CMD.
- The trial will recruit 132 post-menopausal women across Sydney, Melbourne, and Adelaide.
- Participants will receive one or both of the treatments over a 16-week period.
- Advanced cardiac MRI will be used to measure the treatment's effects on the heart's smallest blood vessels and blood flow.
"Our trial will investigate whether treating oestrogen deficiency in post-menopausal women, combined with structured exercise, can improve the function of the heart's smallest blood vessels." — Associate Professor Erin Howden, UNSW Medicine & Health
Funding Source
The trial has received support from Wellcome Leap's VISIBLE program. Wellcome Leap is a U.S.-based nonprofit founded by the Wellcome Trust. The VISIBLE program is described as a global research initiative investing over $75 million (US$55 million) in women's cardiovascular health, with a focus on improving diagnosis and treatment of CMD.
"CMD has too often gone unrecognized and undertreated in women." — Professor Cheryl Jones, UNSW