Clinical trial NCT05530135: Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
Official title: Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Takotsubo Cardiomyopathy
Keywords: Takotsubo Cardiomyopathy
Lead sponsor: University of Aberdeen
Sponsor class: OTHER
Collaborators: name: NHS Grampian
First posted: 2022-09-07
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Three arm pilot feasibility study
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hippocampal volume change
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary outcomes:
measure: Mental wellbeing testing
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
measure: Mental wellbeing testing
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
measure: Mental wellbeing test
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
measure: Exercise Capacity
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
measure: Cardiac Imaging
timeFrame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Other outcomes:
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
Study officials:
References: