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

Not Applicable

Completed

• Conditions: Takotsubo Cardiomyopathy
• Interventions: Other: Exercise program; Other: Cognitive behavioural therapy; Other: Standard clinical care

• Registration Number: NCT05530135
• Lead Sponsor: University of Aberdeen

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. 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.

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 Timeline

• Study Start: 2020-10-06
• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Standard clinical care	Takotsubo patients who will undergo an exercise program in addition to standard care
Control Group	Standard clinical care	Takotsubo patients receiving standard care
Exercise Group	Exercise program	Takotsubo patients who will undergo an exercise program in addition to standard care
CBT Group	Cognitive behavioural therapy	Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care
CBT Group	Standard clinical care	Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care

Primary Outcome Measures

Name	Time	Method
Hippocampal volume change	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention	Brain Magnetic Resonance Imaging

Secondary Outcome Measures

Name	Time	Method
Mental wellbeing test	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention	Cortisol Awakening Response
Cardiac Imaging	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention	Echocardiography
Mental wellbeing testing	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
Exercise Capacity	At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention	6 minute walk test and Cardiopulmonary Exercise Test

Trial Locations

Locations (1)

Aberdeen Royal Infirmary; 🇬🇧 Aberdeen, Scotland, United Kingdom