Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy

Takotsubo Cardiomyopathy Clinical Trial

— BREAKOUT  

Official title:

Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530135
• Other study ID #: 283639
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiomyopathies
• Takotsubo Cardiomyopathy

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