Takotsubo CardiomyopathyBREAKOUTNCT05530135
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
A study testing Exercise program, Cognitive behavioural therapy and Standard clinical care in people with Takotsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Takotsubo Cardiomyopathy
- What is being tested?
- Exercise program, Cognitive behavioural therapy and Standard clinical care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2020to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
About this study
Official title: Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
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.
Read the 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.
- Conditions
- Takotsubo Cardiomyopathy
- Being tested
- Exercise program, Cognitive behavioural therapy, Standard clinical care
- Keywords
- Takotsubo Cardiomyopathy
- Medical subject headings
- Takotsubo Cardiomyopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programOther
Exercise program
Cognitive behavioural therapyOther
Cognitive behavioural therapy
Standard clinical careOther
Standard clinical care
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Takotsubo patients receiving standard care Receives: Other: Standard clinical care |
| Exercise Group | Active comparator | Takotsubo patients who will undergo an exercise program in addition to standard care Receives: Other: Exercise program; Other: Standard clinical care |
| CBT Group | Active comparator | Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care Receives: Other: Cognitive behavioural therapy; Other: Standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hippocampal volume change
Brain Magnetic Resonance Imaging
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Secondary outcomes (5)
Mental wellbeing testing
Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work \& Social Adjustment
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing testing
Blood will be collected for PBMCs isolation and serum cytokine levels
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing test
Cortisol Awakening Response
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Exercise Capacity
6 minute walk test and Cardiopulmonary Exercise Test
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Cardiac Imaging
Echocardiography
Measured: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start6 Oct 2020
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Takotsubo CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Three arm pilot feasibility study
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530135
- Sponsor's protocol ID
- 283639
- Acronym
- BREAKOUT
- Status last verified
- Dec 2023
- First submitted
- 30 Aug 2022
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study
- ClinicalTrials.gov ID
- NCT05530135
- Acronym / sponsor ID
- BREAKOUT / 283639
- Conditions
- Takotsubo Cardiomyopathy
- Keywords
- Takotsubo Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Three arm pilot feasibility study
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Standard clinical careTakotsubo patients receiving standard care |
| Exercise Group | Active comparator | Other: Exercise program, Other: Standard clinical careTakotsubo patients who will undergo an exercise program in addition to standard care |
| CBT Group | Active comparator | Other: Cognitive behavioural therapy, Other: Standard clinical careTakotsubo patients who will receive cognitive behavioural therapy in addition to standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise programExercise program | Other | Exercise Group |
| Cognitive behavioural therapyCognitive behavioural therapy | Other | CBT Group |
| Standard clinical careStandard clinical care | Other | CBT Group, Control Group, Exercise Group |
Primary outcome
Hippocampal volume change
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Brain Magnetic Resonance Imaging
5 secondary outcomes
Mental wellbeing testing
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing testing
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Mental wellbeing test
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Exercise Capacity
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Cardiac Imaging
Time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
Related trials for Takotsubo Cardiomyopathy
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Manganese-enhanced Magnetic Resonance Imaging in Takotsubo Cardiomyopathy
Takotsubo Cardiomyopathy
RecruitingObservational study
Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital
Chronic Obstructive Pulmonary Disease, Takotsubo Cardiomyopathy
RecruitingObservational study
Establishing the Incidence of Tako-tsubo Cardiomyopathy in Scotland
Takotsubo Cardiomyopathy, Myocardial Infarction
RecruitingObservational study
Cardiomyopathies and Heart Muscle Diseases: Cardiac Imaging in the Evaluation of Myocardial Fibrosis Transition
Heart Failure With Preserved Ejection Fraction, Hypertrophic Cardiomyopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise program, Cognitive behavioural therapy and Standard clinical care in people with Takotsubo Cardiomyopathy, run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal volume change (time frame: At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.