Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy (BREAKOUT)
Primary Purpose
Takotsubo Cardiomyopathy
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exercise program
Cognitive behavioural therapy
Standard clinical care
Sponsored by
About this trial
This is an interventional basic science trial for Takotsubo Cardiomyopathy focused on measuring 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
Sites / Locations
- Aberdeen Royal InfirmaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Control Group
Exercise Group
CBT Group
Arm Description
Takotsubo patients receiving standard care
Takotsubo patients who will undergo an exercise program in addition to standard care
Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care
Outcomes
Primary Outcome Measures
Hippocampal volume change
Brain Magnetic Resonance Imaging
Secondary Outcome Measures
Mental wellbeing testing
Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment
Mental wellbeing testing
Blood will be collected for PBMCs isolation and serum cytokine levels
Mental wellbeing test
Cortisol Awakening Response
Exercise Capacity
6 minute walk test and Cardiopulmonary Exercise Test
Cardiac Imaging
Echocardiography
Full Information
NCT ID
NCT05530135
First Posted
August 30, 2022
Last Updated
September 2, 2022
Sponsor
University of Aberdeen
Collaborators
NHS Grampian
1. Study Identification
Unique Protocol Identification Number
NCT05530135
Brief Title
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
Acronym
BREAKOUT
Official Title
Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aberdeen
Collaborators
NHS Grampian
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Takotsubo Cardiomyopathy
Keywords
Takotsubo Cardiomyopathy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Three arm pilot feasibility study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Takotsubo patients receiving standard care
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
Takotsubo patients who will undergo an exercise program in addition to standard care
Arm Title
CBT Group
Arm Type
Active Comparator
Arm Description
Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care
Intervention Type
Other
Intervention Name(s)
Exercise program
Intervention Description
Exercise program
Intervention Type
Other
Intervention Name(s)
Cognitive behavioural therapy
Intervention Description
Cognitive behavioural therapy
Intervention Type
Other
Intervention Name(s)
Standard clinical care
Intervention Description
Standard clinical care
Primary Outcome Measure Information:
Title
Hippocampal volume change
Description
Brain Magnetic Resonance Imaging
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary Outcome Measure Information:
Title
Mental wellbeing testing
Description
Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work & Social Adjustment
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Title
Mental wellbeing testing
Description
Blood will be collected for PBMCs isolation and serum cytokine levels
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Title
Mental wellbeing test
Description
Cortisol Awakening Response
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Title
Exercise Capacity
Description
6 minute walk test and Cardiopulmonary Exercise Test
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Title
Cardiac Imaging
Description
Echocardiography
Time Frame
At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Dawson
Phone
+44 (0)1224 437965
Email
dana.dawson@abdn.ac.uk
Facility Information:
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Dawson
Phone
+44 (0)1224 437965
Email
dana.dawson@abdn.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
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