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

December 7, 2023 updated by: University of Aberdeen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
        • Cardiac Research Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

British Heart Foundation

Investigators

  • Principal Investigator: Dana Dawson, MPhil, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

September 1, 2023

Study Completion (Actual)

September 1, 2023

Study Registration Dates

First Submitted

May 27, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-115-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Takotsubo Cardiomyopathy

Clinical Trials on Physical Exercise Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe