A tier 2 RfPB feasibility (external pilot) study of Hormone replacement therapy in peri and post-menopausal patients with spontaneous coronary artery dissection with chest pain

Project Description

Cardiovascular disease in women has been historically understudied despite evidence of delayed diagnosis and worse outcomes. Spontaneous coronary artery dissection (SCAD) causes unheralded heart attacks or sudden cardiac death. It predominantly afflicts women and some link to female hormones is suggested since SCAD often occurs pre-menstrually, after pregnancy and around the time of the menopause. The precise association is not known but it may be the decline in hormones or fluctuations at these times which increase vulnerability. We have been working with a group of UK SCAD-survivors to deliver research into this condition
https://beatscad.org.uk).
Although the damaged blood vessel heals after SCAD, patients frequently continue to be affected by chest pain for months or years after SCAD, readmissions to hospital are frequent and SCAD can recur (10% risk over 5-years follow-up). Intrusive menopausal symptoms can also impact on patient recovery and patients are frequently advised not to take hormone replacement therapy (HRT) because of the potential link to female sex hormones and
theoretical concerns HRT might make things worse. Patients want to know if they can safely take HRT and if doing so will help their post-SCAD symptoms, particularly chest pains, in addition to their menopausal symptoms.
We already work with international partners to deliver SCAD research and as a group we have just published the discovery of 16 risk genes for SCAD using data from several thousand global patients. We would like to establish an international multicentre trial with our existing research partners to answer our patients questions and investigate the efficacy of body identical HRT (bi-HRT) for post-SCAD chest pain and assess the safety profile of bi-HRT in our
patients.
Before doing this we would like to road-test the feasibility of a HRT clinical trial in this population. This will allow us to check on a smaller scale if we can recruit patients, randomly assign them to treatment with bi-HRT or a dummy version (placebo), and collect sufficient data on their symptoms and outcomes. It will also provide us with information regarding any potential impact of HRT on outcomes to allow us to calculate the number of patients we would need in
a full-scale trial. This will ensure a future, probably multinational, study will provide the data needed to guide patients’
decisions on whether or not HRT helps post-SCAD chest pain and whether HRT in SCAD patients has the same safety profile as non-SCAD patients