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

NCT ID: NCT05530135

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-06

Study Completion Date

2023-08-31

Brief Summary

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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

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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

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Takotsubo Cardiomyopathy

Keywords

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Takotsubo Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Three arm pilot feasibility study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Control Group

Takotsubo patients receiving standard care

Group Type PLACEBO_COMPARATOR

Standard clinical care

Intervention Type OTHER

Standard clinical care

Exercise Group

Takotsubo patients who will undergo an exercise program in addition to standard care

Group Type ACTIVE_COMPARATOR

Exercise program

Intervention Type OTHER

Exercise program

Standard clinical care

Intervention Type OTHER

Standard clinical care

CBT Group

Takotsubo patients who will receive cognitive behavioural therapy in addition to standard care

Group Type ACTIVE_COMPARATOR

Cognitive behavioural therapy

Intervention Type OTHER

Cognitive behavioural therapy

Standard clinical care

Intervention Type OTHER

Standard clinical care

Interventions

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Exercise program

Exercise program

Intervention Type OTHER

Cognitive behavioural therapy

Cognitive behavioural therapy

Intervention Type OTHER

Standard clinical care

Standard clinical care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Grampian

OTHER_GOV

Sponsor Role collaborator

University of Aberdeen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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283639

Identifier Type: -

Identifier Source: org_study_id