Cardiac Research Facility
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
NCT Number: NCT04425785
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. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our 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 improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A structured exercise program
A structured cognitive behavioural therapy program
Time frame: Within three weeks after diagnosis
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Time frame: At completion of 12 weeks intervention
Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
Time frame: Within three weeks after diagnosis
Echocardiography
Time frame: At completion of 12 weeks intervention
Echocardiography
Time frame: Within three weeks after diagnosis
6 minute walk test and Cardiopulmonary Exercise Test
Time frame: At completion of 12 weeks intervention
6 minute walk test and Cardiopulmonary Exercise Test
Time frame: Within three weeks after diagnosis
Index of Mental Wellbeing and Cortisol Awakening Response
Time frame: At completion of 12 weeks intervention
Index of Mental Wellbeing and Cortisol Awakening Response
University of Aberdeen
Other
Acronym: PLEASE
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