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

University of Aberdeen

Status: Completed

Conditions: Takotsubo Cardiomyopathy

Treatments: Other: Exercise program; Other: Standard clinical care; Other: Cognitive behavioural therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05530135

283639

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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85 participants in 3 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Takotsubo patients receiving standard care

Treatment:

Other: Standard clinical care

Exercise Group

Active Comparator group

Description:

Takotsubo patients who will undergo an exercise program in addition to standard care

Treatment:

Other: Standard clinical care

Other: Exercise program

CBT Group

Active Comparator group

Description:

Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care

Treatment:

Other: Standard clinical care

Other: Cognitive behavioural therapy