Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
NCT Number: NCT05530135
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Aberdeen, Scotland, AB25 2ZN, United Kingdom
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Exercise program
Cognitive behavioural therapy
Standard clinical care
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Brain Magnetic Resonance Imaging
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Blood will be collected for PBMCs isolation and serum cytokine levels
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Cortisol Awakening Response
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
6 minute walk test and Cardiopulmonary Exercise Test
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Echocardiography
University of Aberdeen
Other
Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
Acronym: BREAKOUT
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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