HRT-SCAD
Research type
Research Study
Full title
A pilot study of Hormone replacement therapy in peri and post-menopausal patients with spontaneous coronary artery dissection and chest pain (HRT-SCAD).
IRAS ID
1010557
Contact name
David Adlam
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN18011296
Research summary
Spontaneous coronary artery dissection (SCAD) is an important cause of heart attacks in young and middle-aged women, particularly those of peri-menopausal age. Many patients who have had SCAD experience chest pain for many months or years after the event. We call this post-SCAD chest pain. Other studies have shown hormone replacement therapy (HRT) can help with similar chest pain where the coronary arteries are not obstructed. We have also noticed improvements in cyclical post-SCAD chest pain with hormonal treatment in SCAD patients of child-bearing age. Our patients would like to know if HRT will help post-SCAD chest pain in peri-menopausal patients. As the first step to answering this question we are conducting a pilot clinical trial where patients with SCAD will be randomly treated with either HRT or placebo. Neither the patients nor the doctors will know which treatment they are taking. This will allow us to see if a larger clinical trial is feasible and acceptable to patients. It will also provide important preliminary data on symptom outcomes and allow us to study the effect of HRT on the heart and blood vessels of SCAD patients. We will ask 60 peri and post-menopausal patients aged ≥45 years with SCAD in the past 3-years and chest pain. Patients will receive 12 months of treatment and will be followed up at 3, 6 and 12 months. The study will be conducted at the UKs national SCAD centre in Leicester. This will be the first clinical trial to study HRT in SCAD patients and is a critical first step in answering patient questions about whether it will help post-SCAD chest pain. This study has been developed from inception in partnership with our patient group (https://beatscad.org.uk/) and a SCAD patient will be part of the study management group for the duration of the study.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0121
Date of REC Opinion
30 Jul 2025
REC opinion
Further Information Favourable Opinion