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Completed

NCT Number: NCT05530135

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exercise program

Other

Exercise program

Cognitive Behavioural Therapy

Other

Cognitive behavioural therapy

Standard clinical care

Other

Standard clinical care

Primary outcomes

  1. Hippocampal volume change

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    Brain Magnetic Resonance Imaging

Secondary outcomes

  1. Mental wellbeing testing

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment

  2. Mental wellbeing testing

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    Blood will be collected for PBMCs isolation and serum cytokine levels

  3. Mental wellbeing test

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    Cortisol Awakening Response

  4. Exercise Capacity

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    6 minute walk test and Cardiopulmonary Exercise Test

  5. Cardiac Imaging

    Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention

    Echocardiography

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Collaborators

  • NHS Grampian

Registry information

Official study title

Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study

Acronym: BREAKOUT

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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