Takotsubo Cardiomyopathy
Conditions
Keywords
Takotsubo Cardiomyopathy
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.
Interventions
OTHERExercise program
Exercise program
OTHERCognitive behavioural therapy
Cognitive behavioural therapy
Standard clinical care
Sponsors
NHS Grampian
University of Aberdeen
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Three arm pilot feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hippocampal volume change | At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention | Brain Magnetic Resonance Imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mental wellbeing testing | At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention | Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment |
| Mental wellbeing test | At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention | Cortisol Awakening Response |
| Exercise Capacity | At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention | 6 minute walk test and Cardiopulmonary Exercise Test |
| Cardiac Imaging | At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention | Echocardiography |
Countries
United Kingdom
Outcome results
None listed