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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Takotsubo Cardiomyopathy

Intervention / Treatment
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* Other: Physical Exercise Program
* Behavioral: Cognitive Behavioural Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled study. Takotsubo patients will be randomised into one of the following groups: Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Exercise Group<br>A structured exercise program for 12 weeks | Other: Physical Exercise Program<br>* A structured exercise program<br>|
| Experimental: Cognitive Behavioural Therapy<br>Cognitive Behavioural Therapy for 12 weeks | Behavioral: Cognitive Behavioural Therapy<br>* A structured cognitive behavioural therapy program<br>|
| No Intervention: Standard Clinical Care<br>Standard Clinical Care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Energetics | Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy | Within three weeks after diagnosis | 
| Cardiac Energetics | Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy | At completion of 12 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Global Longitudinal Strain | Echocardiography | Within three weeks after diagnosis | 
| Left Ventricular Global Longitudinal Strain | Echocardiography | At completion of 12 weeks intervention | 
| Exercise Capacity | 6 minute walk test and Cardiopulmonary Exercise Test | Within three weeks after diagnosis | 
| Exercise Capacity | 6 minute walk test and Cardiopulmonary Exercise Test | At completion of 12 weeks intervention | 
| Mental status and Stress | Index of Mental Wellbeing and Cortisol Awakening Response | Within three weeks after diagnosis | 
| Mental status and Stress | Index of Mental Wellbeing and Cortisol Awakening Response | At completion of 12 weeks intervention |