CompletedNot Applicable

Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy

United Kingdom85 participantsStarted 2020-10-06

Plain-language summary

Takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. Recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. The purpose of this study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of Takotsubo will result in significant improvement in the brain activity, general and mental wellbeing of patients.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients diagnosed with takotsubo cardiomyopathy in the previous three weeks * Participant who is willing and able to give informed consent for participation in the study. * Participant who is willing to travel to Aberdeen Royal Infirmary for the study visits. * Healthy volunteers (for blood and saliva samples only) willing to give informed consent for participation in the study. Healthy volunteers should not be on any medication. * For influenza T-Cell testing: healthy volunteers who have recently received their annual flu vaccination. * Myocardial Infarction (MI) comparators: patients with type 1 acute MI (diagnosed within the last three weeks) Exclusion Criteria: * Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program * Any patient who is not able or willing to travel to the cardiovascular research facility for their study visits * Any patient who is not able to commit to a 12 week supervised training program * Inability to exercise on a cycle ergometer or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty) * Unwillingness to participate * Contraindication to MRI scanning such as implantable cardiac devices. * Pregnancy * Healthy volunteers taking medication

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hippocampal volume change

Timeframe: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

Trial details

NCT IDNCT05530135

SponsorUniversity of Aberdeen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Takotsubo Cardiomyopathy trials