NCT05530135

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: University of Aberdeen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Takotsubo Cardiomyopathy

Interventions

Type	Name	Description
OTHER	Exercise program	Exercise program
OTHER	Cognitive behavioural therapy	Cognitive behavioural therapy
OTHER	Standard clinical care	Standard clinical care

Timeline

• Start date: 2020-10-06
• Primary completion: 2023-08-31
• Completion: 2023-08-31
• First posted: 2022-09-07
• Last updated: 2023-12-08

Locations

1 site across 1 country: United Kingdom