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

  • End date
    Aug 14, 2023
  • participants needed
  • sponsor
    University of Aberdeen
Updated on 7 October 2022
Accepts healthy volunteers


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.


Takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. This neuro-cardiac condition has a 5-year morbidity and mortality comparable with acute myocardial infarction and no current therapies exist. The psycho-somatic basis of Takotsubo suggests that its neuro-biology could be amenable to modulation. Here, the investigators propose a mechanistic three-arm pilot feasibility trial of standardised physical exercise training, cognitive behavioural therapy and current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.

Condition Takotsubo Cardiomyopathy
Treatment Cognitive Behavioural Therapy, Exercise Program, Standard Clinical Care
Clinical Study IdentifierNCT05530135
SponsorUniversity of Aberdeen
Last Modified on7 October 2022


Yes No Not Sure

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
Healthy volunteers taking medication
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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