Effects of Menopausal Hormone Therapy on QTc in Genetically Confirmed Long QT Syndrome: A Prospective Randomized Sequential Crossover Study with Long-Term Observational Follow-Up (LQTS-HER)
Many women use hormone replacement therapy (HRT) to relieve menopause symptoms like hot flushes and mood changes. However, hormones can affect the heart's electrical system. For women with Long QT syndrome—a genetic condition that slows down how the heart recharges between beats—there is limited information about HRT safety. This trial investigates how different HRT medications, including skin patches, gels, sprays, and capsules, affect the heart's rhythm. Participants will try different hormone treatments for four weeks at a time while having regular heart checks. Doctors will track changes using standard heart tracings (ECGs) and a tiny heart monitor placed just under the skin. By closely monitoring heart activity, researchers hope to discover which hormone treatments are safest. This will help doctors give clear, safe advice to women with Long QT syndrome going through menopause in the future.
At a glance
What is this study about?
Long QT syndrome is an inherited condition that affects the heart's electrical system. In people with this condition, the heart muscle takes slightly longer than normal to recharge between beats. While many people live normal lives, certain triggers—such as medications or hormone shifts—can sometimes cause abnormal heart rhythms.
During menopause, falling hormone levels often cause troublesome symptoms, such as hot flushes, sleep problems, and night sweats. Hormone replacement therapy (HRT) is the most effective treatment for these symptoms. However, because natural and synthetic female hormones can influence electrical signals in the heart, women with Long QT syndrome and their doctors are often unsure whether HRT is safe to use.
This study, called LQTS-HER, aims to provide clear answers. Over several four-week periods, participants will receive common types of HRT, such as oestrogen skin patches, gels, or sprays, alongside progesterone capsules. Researchers will measure the heart's electrical timing (known as the QT interval) during each stage to see if any specific hormone type causes concerning changes.
The findings could make a huge difference to patient care. If researchers can show which HRT options are safe, women with Long QT syndrome will no longer have to suffer through severe menopause symptoms without treatment, giving them and their cardiologists greater confidence and peace of mind.
Key takeaways
- The study tests whether hormone replacement therapy (HRT) is safe for women with Long QT syndrome.
- Participants test different types of HRT, including patches, gels, sprays, and capsules, in four-week blocks.
- Heart rhythms are closely checked using regular ECGs and a tiny under-the-skin heart monitor.
- The trial aims to give women safe options for managing menopause symptoms.
- Participation is entirely voluntary and you can withdraw at any time.
Who may be eligible?
This study is designed for adult women who have a confirmed genetic diagnosis of Long QT syndrome. If you have had genetic testing that confirmed you carry a gene linked to the condition, you may be able to take part.
Participants will generally be women who are approaching or going through menopause, or who have already reached menopause and are considering HRT to help manage symptoms.
Because this study tests female hormone therapies, it is only open to women aged 18 and older. If you have other complex heart conditions or medical reasons why you cannot safely use HRT, the study team will review your records to check if taking part is suitable and safe for you.
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.
- I am a woman aged 18 or over.
- I have been genetically diagnosed with Long QT syndrome.
- I am experiencing menopause symptoms or considering HRT.
- I am willing to attend regular hospital visits for heart checks.
- I am happy to have a small heart monitor placed under my skin for safety.
What does participation involve?
If you decide to take part, you will be asked to try different forms of HRT in planned four-week blocks. These treatments may include oestrogen patches, skin gels, sprays, and oral progesterone capsules. During the study, your heart will be monitored very closely. You will have regular 12-lead ECGs (painless stickers placed on your chest to record heart signals) and will be fitted with an implantable loop recorder—a tiny heart monitor inserted just under the skin during a quick, simple outpatient procedure. You will also fill out short questionnaires about your menopause symptoms to see how the treatments are helping. After testing the different treatments, you may be invited to continue in a longer-term follow-up phase so doctors can track your health over time. In total, the active testing phase lasts several months, followed by ongoing routine check-ups.
Potential risks and benefits
Locations (1)
- —UnverifiedNorway
Common questions
What is Long QT syndrome?
It is an inherited heart condition where the heart's electrical system takes longer than usual to recharge after each beat. It is usually diagnosed through an ECG and a genetic blood test.
What is an implantable loop recorder?
It is a very small, slim monitoring device placed just under the skin of your chest. It works automatically in the background to record your heart rhythm 24 hours a day.
Will I definitely get HRT in this study?
Yes. This study tests different standard forms of HRT, such as gels, sprays, patches, and capsules, to compare how each one affects your heart rhythm.
Can I leave the study if I change my mind?
Yes, you can leave at any point without giving a reason. Your standard medical care and relationship with your doctors will not be affected in any way.
Does this trial replace my normal heart medication?
No. You will continue to take your prescribed heart medications, such as beta-blockers, exactly as directed by your cardiologist.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.