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

Takotsubo Cardiomyopathy Clinical Trial

— PLEASE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425785
• Other study ID #: 2-115-18
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 1, 2023

Study information

• Verified date: December 2023
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

Intervention

Other:
• Physical Exercise Program
A structured exercise program

Behavioral:
• Cognitive Behavioural Therapy
A structured cognitive behavioural therapy program

Locations

Country	Name	City	State
United Kingdom	Cardiac Research Facility	Aberdeen	Aberdeenshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Aberdeen	British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Energetics	Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy	Within three weeks after diagnosis
Primary	Cardiac Energetics	Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy	At completion of 12 weeks intervention
Secondary	Left Ventricular Global Longitudinal Strain	Echocardiography	Within three weeks after diagnosis
Secondary	Left Ventricular Global Longitudinal Strain	Echocardiography	At completion of 12 weeks intervention
Secondary	Exercise Capacity	6 minute walk test and Cardiopulmonary Exercise Test	Within three weeks after diagnosis
Secondary	Exercise Capacity	6 minute walk test and Cardiopulmonary Exercise Test	At completion of 12 weeks intervention
Secondary	Mental status and Stress	Index of Mental Wellbeing and Cortisol Awakening Response	Within three weeks after diagnosis
Secondary	Mental status and Stress	Index of Mental Wellbeing and Cortisol Awakening Response	At completion of 12 weeks intervention