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RecruitingPhase IIInterventional

Use of hormone replacement therapy in the management of chest pain after spontaneous coronary artery dissection in peri and post-menopausal women

This study is investigating if hormone replacement therapy (HRT) can ease chest pain in women who have experienced a condition called spontaneous coronary artery dissection (SCAD) and are either going through or have finished menopause. SCAD is when a bruise appears in a heart artery, often healing by itself, but can cause ongoing chest pain. This pain, though usually harmless, can be distressing. The research aims to find out if HRT is a safe and effective way to manage this discomfort and whether a larger study should be done in the future. Women aged 45 or over with a recent SCAD history and regular chest pain can take part, but certain medical conditions would prevent participation.

At a glance

Status
Recruiting
Phase
Phase II
Sponsor
University of Leicester
Enrolment target
60
Start
15 Aug 2025
Estimated completion
15 Aug 2026

What is this study about?

Spontaneous coronary artery dissection, or SCAD, is a heart condition where a bruise unexpectedly appears in the wall of one of the main arteries supplying blood to your heart. Usually, this bruise heals on its own without needing surgery, and people generally recover well. However, it's very common for women who have had SCAD to continue experiencing chest pain afterwards. This pain, often called post-SCAD chest pain, can be quite uncomfortable and worrying, sometimes even leading to hospital visits, even though doctors believe it's not harmful to the heart itself.

This research study is looking at whether hormone replacement therapy (HRT) could be a helpful treatment for this ongoing chest pain in women who are going through menopause or have already finished it, and have previously had SCAD. HRT involves taking hormones to replace those that decrease during menopause. The main goal is to see if HRT can safely and effectively reduce this chest pain, and if so, whether a bigger study should be carried out in the future to confirm these findings.

By taking part, you would be helping doctors understand more about post-SCAD chest pain and exploring a potential new treatment option. Your involvement could help many other women who experience this distressing symptom, improving their quality of life after a SCAD event.

Key takeaways

  • This study is for women aged 45+ who have had SCAD and ongoing chest pain.
  • It's testing if Hormone Replacement Therapy (HRT) can reduce post-SCAD chest pain.
  • Participants will receive either HRT or a dummy treatment for 12 months.
  • The study aims to check if HRT is safe and effective for this specific group.
  • You'll need to use a mobile app to track your daily chest pain.
  • You can stop participating at any time.

Who may be eligible?

This study is looking for women aged 45 or older who are either starting menopause (perimenopausal) or have finished it (post-menopausal). You also need to have had a SCAD event confirmed by a doctor in the last three years and be experiencing chest pain on at least four days in the past month.

However, there are some reasons why you might not be able to join. For example, if you are currently taking HRT, or if you have certain medical conditions such as a history of stroke, blood clots, or certain types of cancer (like breast, womb, or ovarian cancer). You also can't take part if you are pregnant, breastfeeding, or have given birth in the last year. If you have severe liver problems or other serious health issues that the study doctors decide might affect your participation, you would also be unable to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman aged 45 or older?
  2. Are you going through or have you finished menopause?
  3. Have you had a SCAD event in the last three years?
  4. Do you experience chest pain at least four days a month?
  5. Are you NOT currently taking HRT?
  6. Do you NOT have a history of stroke, blood clots, or certain cancers?
Answer every question to see your result.

What does participation involve?

If you join the study, you'll be randomly put into one of two groups: one group will receive the HRT medicine, and the other will get a 'dummy' treatment called a placebo. You won't know which one you're receiving, and neither will the study team. The HRT involves a gel that you rub on your skin daily (containing oestrogen) and capsules you take by mouth (containing progesterone). If your chest pain isn't improving, the dose of the oestrogen gel might be increased.

You'll take the treatment for 12 months. During this time, you'll have follow-up appointments at 3, 6, and 12 months where the team will check your chest pain, menopausal symptoms, overall well-being, and any side effects. You'll also use a special mobile app to record your chest pain symptoms each day. The study is expected to run from June 2025 to July 2027.

Potential risks and benefits

Taking part in this study could offer several potential benefits, such as a reduction in your chest pain and an improvement in menopausal symptoms. You would also be helping researchers understand whether HRT is a safe and effective treatment for women who have had SCAD. As with any medication, there are possible side effects from HRT, which could include headaches, changes in blood pressure, or, in rare cases, more serious issues like blood clots or allergic reactions. The study team will closely monitor your health throughout your participation to help manage any concerns. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • -
    Unverified
    United Kingdom

Common questions

What is SCAD?

SCAD stands for spontaneous coronary artery dissection. It's a condition where a bruise forms in the wall of an artery that supplies blood to the heart.

What is HRT?

HRT stands for hormone replacement therapy. It's a treatment that replaces hormones (like oestrogen and progesterone) that naturally decrease when women go through menopause.

Will I definitely get HRT if I join?

No, participants will be randomly assigned to either receive HRT or a placebo (a dummy treatment). You won't know which one you're getting.

How long will the study last for me?

If you join, you will be involved for 12 months, which includes taking the treatment and attending follow-up checks.

Who is funding this research?

The study is being funded by the National Institute for Health and Care Research (NIHR), with additional support from other organisations.

How to find out more

David Adlam

Always speak to your GP or specialist before deciding to take part in a study.

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