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Completed

NCT Number: NCT04425785

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiac Research Facility

Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise program

Other

A structured exercise program

Cognitive Behavioural Therapy

Behavioral

A structured cognitive behavioural therapy program

Primary outcomes

  1. Cardiac Energetics

    Time frame: Within three weeks after diagnosis

    Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

  2. Cardiac Energetics

    Time frame: At completion of 12 weeks intervention

    Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

Secondary outcomes

  1. Left Ventricular Global Longitudinal Strain

    Time frame: Within three weeks after diagnosis

    Echocardiography

  2. Left Ventricular Global Longitudinal Strain

    Time frame: At completion of 12 weeks intervention

    Echocardiography

  3. Exercise Capacity

    Time frame: Within three weeks after diagnosis

    6 minute walk test and Cardiopulmonary Exercise Test

  4. Exercise Capacity

    Time frame: At completion of 12 weeks intervention

    6 minute walk test and Cardiopulmonary Exercise Test

  5. Mental status and Stress

    Time frame: Within three weeks after diagnosis

    Index of Mental Wellbeing and Cortisol Awakening Response

  6. Mental status and Stress

    Time frame: At completion of 12 weeks intervention

    Index of Mental Wellbeing and Cortisol Awakening Response

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • British Heart Foundation

Registry information

Acronym: PLEASE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 11, 2020
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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