Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy (BREAKOUT)

Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT 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. The purpose of this 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 result in significant improvement in the brain activity, general and mental wellbeing of patients.

Study Overview

• Status: Completed
• Conditions: Takotsubo Cardiomyopathy
• Intervention / Treatment: Other: Standard clinical care; Other: Exercise program; Other: Cognitive behavioural therapy

Detailed Description

Takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. This neuro-cardiac condition has a 5-year morbidity and mortality comparable with acute myocardial infarction and no current therapies exist. The psycho-somatic basis of Takotsubo suggests that its neuro-biology could be amenable to modulation. Here, the investigators propose a mechanistic three-arm pilot feasibility trial of standardised physical exercise training, cognitive behavioural therapy and current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients diagnosed with takotsubo cardiomyopathy in the previous three weeks
• Participant who is willing and able to give informed consent for participation in the study.
• Participant who is willing to travel to Aberdeen Royal Infirmary for the study visits.
• Healthy volunteers (for blood and saliva samples only) willing to give informed consent for participation in the study. Healthy volunteers should not be on any medication.
• For influenza T-Cell testing: healthy volunteers who have recently received their annual flu vaccination.
• Myocardial Infarction (MI) comparators: patients with type 1 acute MI (diagnosed within the last three weeks)

Exclusion Criteria:

• Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program
• Any patient who is not able or 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 or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty)
• Unwillingness to participate
• Contraindication to MRI scanning such as implantable cardiac devices.
• Pregnancy
• Healthy volunteers taking medication

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group; Takotsubo patients receiving standard care	Other: Standard clinical care; Standard clinical care
Active Comparator: Exercise Group; Takotsubo patients who will undergo an exercise program in addition to standard care	Other: Standard clinical care; Standard clinical care; Other: Exercise program; Exercise program
Active Comparator: CBT Group; Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care	Other: Standard clinical care; Standard clinical care; Other: Cognitive behavioural therapy; Cognitive behavioural therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hippocampal volume change	Brain Magnetic Resonance Imaging	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental wellbeing testing	Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing testing	Blood will be collected for PBMCs isolation and serum cytokine levels	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing test	Cortisol Awakening Response	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Exercise Capacity	6 minute walk test and Cardiopulmonary Exercise Test	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Cardiac Imaging	Echocardiography	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

Collaborators and Investigators

• Sponsor: University of Aberdeen
• Collaborators: NHS Grampian

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2020
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): 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

• Keywords: Takotsubo Cardiomyopathy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction, Left; Ventricular Dysfunction; Cardiomyopathies; Takotsubo Cardiomyopathy
• Other Study ID Numbers: 283639

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No