Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05530135
Other study ID # 283639
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 6, 2020
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exercise program
Exercise program
Cognitive behavioural therapy
Cognitive behavioural therapy
Standard clinical care
Standard clinical care

Locations

Country Name City State
United Kingdom Aberdeen Royal Infirmary Aberdeen Scotland

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen NHS Grampian

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hippocampal volume change Brain Magnetic Resonance Imaging At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Mental wellbeing testing Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Mental wellbeing testing Blood will be collected for PBMCs isolation and serum cytokine levels At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Mental wellbeing test Cortisol Awakening Response At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Exercise Capacity 6 minute walk test and Cardiopulmonary Exercise Test At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Cardiac Imaging Echocardiography At =3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
See also
  Status Clinical Trial Phase
Recruiting NCT04325321 - The Broken Heart Study II (BHS-II) N/A
Recruiting NCT03663348 - Registry of Patients With Takotsubo Syndrome
Recruiting NCT04695587 - The Role of Sympathetic Tone Regarding the Anatomical and Functional Recovery of the Left Ventricle in TakoTsubo Syndrome
Not yet recruiting NCT05946772 - Cyclosporine In Takotsubo Syndrome Phase 2
Completed NCT02240056 - Brain fMRT In Takotsubo Cardiomyopathy
Completed NCT02307214 - Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: New Insights Into the Pathophysiology N/A
Recruiting NCT05977049 - Psychosocial Support for Patients With Takotsubo Syndrome N/A
Recruiting NCT06277297 - Prognotic Role of CMR in Takotsubo Syndrome
Completed NCT03787810 - Left Ventricular Dysfunction in Critically Ill Patients
Active, not recruiting NCT00123695 - Serial Echocardiography After Subarachnoid Hemorrhage N/A
Recruiting NCT05793008 - Characterization of priMary And sEcondary STress Related takOtsubo N/A
Recruiting NCT04513054 - Is There a Genetic Predisposition for Acute Stress-induced (Takotsubo) Cardiomyopathy N/A
Completed NCT04425785 - Physical Exercise and Mental Wellbeing Rehabilitation for Acute Stress-induced Takotsubo Cardiomyopathy: The PLEASE Study N/A
Recruiting NCT02361073 - The Role of Emotional Stress in Patients With Stress-induced Cardiomyopathy N/A
Recruiting NCT06323811 - Comparison of Free-breathing 3D Quantitative Perfusion in Patients With MINOCA and MINOCA-mimics N/A
Recruiting NCT03299569 - Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Recruiting NCT01947621 - International Takotsubo Registry (InterTAK Registry) N/A
Completed NCT04684004 - Hyperglycemia in Patients With Takotsubo Syndrome
Completed NCT02759341 - Brain-heart Interactions in Tako-Tsubo Cardiomyopathy and Cardiac Syndrome X: N/A
Completed NCT02659878 - Takotsubo Cardiomyopathy in Patients Suffering From Acute Non-traumatic Subarachnoid Hemorrhage