Clinical trial NCT04425785: Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
Official title: Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Takotsubo Cardiomyopathy
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
First posted: 2020-06-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled study. Takotsubo patients will be randomised into one of the following groups:

Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cardiac Energetics
timeFrame: Within three weeks after diagnosis
measure: Cardiac Energetics
timeFrame: At completion of 12 weeks intervention
Secondary outcomes:
measure: Left Ventricular Global Longitudinal Strain
timeFrame: Within three weeks after diagnosis
measure: Left Ventricular Global Longitudinal Strain
timeFrame: At completion of 12 weeks intervention
measure: Exercise Capacity
timeFrame: Within three weeks after diagnosis
measure: Exercise Capacity
timeFrame: At completion of 12 weeks intervention
measure: Mental status and Stress
timeFrame: Within three weeks after diagnosis
measure: Mental status and Stress
timeFrame: At completion of 12 weeks intervention
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Cardiac Research Facility
state: Aberdeenshire
Study officials:
affiliation: University of Aberdeen
name: Dana Dawson, MPhil
role: PRINCIPAL_INVESTIGATOR
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