Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study (PLEASE)

  • STATUS
    Recruiting
  • End date
    Jul 20, 2023
  • participants needed
    90
  • sponsor
    University of Aberdeen
Updated on 7 October 2022

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. 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.

Description

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.

Details
Condition Takotsubo Cardiomyopathy
Treatment Cognitive Behavioural Therapy, Physical Exercise Program
Clinical Study IdentifierNCT04425785
SponsorUniversity of Aberdeen
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks
Participant who is willing and able to give informed consent for participation in the study

Exclusion Criteria

Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program
Any patient who is not able or not 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 (i.e. use of walking aids or prosthetic limbs)
Contraindication to magnetic resonance scanning such as an implantable cardiac device
Pregnancy
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