The BREAKOUT Study
Research type
Research Study
Full title
Life-style Interventions for modulating the BRain PhEnotype of TAKOtsUbo CardiomyopaThy The BREAKOUT Study
IRAS ID
283639
Contact name
Dana Dawson
Contact email
Sponsor organisation
University of Aberdeen
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
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, we 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. The primary end-point will be the between groups difference in hippocampal volume change from the acute phase (< 3 weeks from presentation) to follow-up (12 weeks post-randomisation). If successful, this will uncover a measurable brain biomarker of successful therapy in takotsubo cardiomyopathy and will guide towards best neuro-pharmacological interventions in this potentially fatal condition.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0305
Date of REC Opinion
15 Sep 2020
REC opinion
Further Information Favourable Opinion