Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-29 @ 11:08 AM
Study NCT ID:
NCT05530135
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
Sponsor:
University of Aberdeen
Organization:
Study Overview
Official Title:
Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREAKOUT
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: