Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-29 @ 11:08 AM
Study NCT ID:
NCT05530135
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2022-08-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054549', 'term': 'Takotsubo Cardiomyopathy'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D018487', 'term': 'Ventricular Dysfunction, Left'}, {'id': 'D018754', 'term': 'Ventricular Dysfunction'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D055070', 'term': 'Resistance Training'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Three arm pilot feasibility study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-07', 'studyFirstSubmitDate': '2022-08-30', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2023-12-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hippocampal volume change', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': 'Brain Magnetic Resonance Imaging'}], 'secondaryOutcomes': [{'measure': 'Mental wellbeing testing', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': 'Eysenck personality questionnaires, Hospital Anxiety and Depression, Perceived Stress Scale and Work \\& Social Adjustment'}, {'measure': 'Mental wellbeing testing', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': 'Blood will be collected for PBMCs isolation and serum cytokine levels'}, {'measure': 'Mental wellbeing test', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': 'Cortisol Awakening Response'}, {'measure': 'Exercise Capacity', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': '6 minute walk test and Cardiopulmonary Exercise Test'}, {'measure': 'Cardiac Imaging', 'timeFrame': 'At ≤3 weeks of diagnosis of takotsubo cardiomyopathy and repeated at completion of 12 weeks intervention', 'description': 'Echocardiography'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Takotsubo Cardiomyopathy'], 'conditions': ['Takotsubo Cardiomyopathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with takotsubo cardiomyopathy in the previous three weeks\n* Participant who is willing and able to give informed consent for participation in the study.\n* Participant who is willing to travel to Aberdeen Royal Infirmary for the study visits.\n* 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.\n* For influenza T-Cell testing: healthy volunteers who have recently received their annual flu vaccination.\n* Myocardial Infarction (MI) comparators: patients with type 1 acute MI (diagnosed within the last three weeks)\n\nExclusion Criteria:\n\n* Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program\n* Any patient who is not able or willing to travel to the cardiovascular research facility for their study visits\n* Any patient who is not able to commit to a 12 week supervised training program\n* Inability to exercise on a cycle ergometer or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty)\n* Unwillingness to participate\n* Contraindication to MRI scanning such as implantable cardiac devices.\n* Pregnancy\n* Healthy volunteers taking medication'}, 'identificationModule': {'nctId': 'NCT05530135', 'acronym': 'BREAKOUT', 'briefTitle': 'Life-style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aberdeen'}, 'officialTitle': 'Life-Style Interventions for Modulating the Brain Phenotype of Takotsubo Cardiomyopathy - the BREAKOUT Study', 'orgStudyIdInfo': {'id': '283639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Takotsubo patients receiving standard care', 'interventionNames': ['Other: Standard clinical care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Exercise Group', 'description': 'Takotsubo patients who will undergo an exercise program in addition to standard care', 'interventionNames': ['Other: Exercise program', 'Other: Standard clinical care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CBT Group', 'description': 'Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care', 'interventionNames': ['Other: Cognitive behavioural therapy', 'Other: Standard clinical care']}], 'interventions': [{'name': 'Exercise program', 'type': 'OTHER', 'description': 'Exercise program', 'armGroupLabels': ['Exercise Group']}, {'name': 'Cognitive behavioural therapy', 'type': 'OTHER', 'description': 'Cognitive behavioural therapy', 'armGroupLabels': ['CBT Group']}, {'name': 'Standard clinical care', 'type': 'OTHER', 'description': 'Standard clinical care', 'armGroupLabels': ['CBT Group', 'Control Group', 'Exercise Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'AB25 2ZN', 'city': 'Aberdeen', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Aberdeen Royal Infirmary', 'geoPoint': {'lat': 57.14369, 'lon': -2.09814}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aberdeen', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Grampian', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}