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| Name | Class |
|---|---|
| British Heart Foundation | OTHER |
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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. Research conducted in our unit has found that the heart function does not recover fully as is commonly believed and that the energetic status of the heart remains impaired for an extended period of time. The purpose of our 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 improve the energy status of the heart, their physical conditioning and improve the general mental wellbeing of patients.
Acute takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. The researchers have shown that recovery is more protracted than previously appreciated, and is associated with persistent major morbidity and a long-term heart failure phenotype. In the absence of any effective therapeutic options, the researchers propose a mechanistic three-arm pilot feasibility trial of early rehabilitation (standardised physical exercise training or cognitive behavioural therapy) versus current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy. The primary end-point will be the restoration of cardiac energetic status assessed by 31P-magnetic resonance spectroscopy and the secondary end-points of cortisol awakening response, global longitudinal strain by echocardiography and the 6-minute walk test. If successful, this has the potential for rapid implementation into a large randomised clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical Exercise Group | Experimental | A structured exercise program for 12 weeks |
|
| Cognitive Behavioural Therapy | Experimental | Cognitive Behavioural Therapy for 12 weeks |
|
| Standard Clinical Care | No Intervention | Standard Clinical Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Exercise Program | Other | A structured exercise program |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Energetics | Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy | Within three weeks after diagnosis |
| Cardiac Energetics | Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy | At completion of 12 weeks intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Left Ventricular Global Longitudinal Strain | Echocardiography | Within three weeks after diagnosis |
| Left Ventricular Global Longitudinal Strain | Echocardiography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dana Dawson, MPhil | University of Aberdeen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac Research Facility | Aberdeen | Aberdeenshire | AB25 2ZN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18294473 | Background | Prasad A, Lerman A, Rihal CS. Apical ballooning syndrome (Tako-Tsubo or stress cardiomyopathy): a mimic of acute myocardial infarction. Am Heart J. 2008 Mar;155(3):408-17. doi: 10.1016/j.ahj.2007.11.008. Epub 2008 Jan 31. | |
| 26332547 | Background | Templin C, Ghadri JR, Diekmann J, Napp LC, Bataiosu DR, Jaguszewski M, Cammann VL, Sarcon A, Geyer V, Neumann CA, Seifert B, Hellermann J, Schwyzer M, Eisenhardt K, Jenewein J, Franke J, Katus HA, Burgdorf C, Schunkert H, Moeller C, Thiele H, Bauersachs J, Tschope C, Schultheiss HP, Laney CA, Rajan L, Michels G, Pfister R, Ukena C, Bohm M, Erbel R, Cuneo A, Kuck KH, Jacobshagen C, Hasenfuss G, Karakas M, Koenig W, Rottbauer W, Said SM, Braun-Dullaeus RC, Cuculi F, Banning A, Fischer TA, Vasankari T, Airaksinen KE, Fijalkowski M, Rynkiewicz A, Pawlak M, Opolski G, Dworakowski R, MacCarthy P, Kaiser C, Osswald S, Galiuto L, Crea F, Dichtl W, Franz WM, Empen K, Felix SB, Delmas C, Lairez O, Erne P, Bax JJ, Ford I, Ruschitzka F, Prasad A, Luscher TF. Clinical Features and Outcomes of Takotsubo (Stress) Cardiomyopathy. N Engl J Med. 2015 Sep 3;373(10):929-38. doi: 10.1056/NEJMoa1406761. |
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| ID | Term |
|---|---|
| D054549 | Takotsubo Cardiomyopathy |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018487 | Ventricular Dysfunction, Left |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Randomised controlled study. Takotsubo patients will be randomised into one of the following groups:
Exercise Arm Cognitive Behavioural Arm Standard Clinical Care
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| Cognitive Behavioural Therapy |
| Behavioral |
A structured cognitive behavioural therapy program |
|
| At completion of 12 weeks intervention |
| Exercise Capacity | 6 minute walk test and Cardiopulmonary Exercise Test | Within three weeks after diagnosis |
| Exercise Capacity | 6 minute walk test and Cardiopulmonary Exercise Test | At completion of 12 weeks intervention |
| Mental status and Stress | Index of Mental Wellbeing and Cortisol Awakening Response | Within three weeks after diagnosis |
| Mental status and Stress | Index of Mental Wellbeing and Cortisol Awakening Response | At completion of 12 weeks intervention |
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| 41332388 | Derived | Gamble DT, Ross J, Khan H, Cheyne L, Rudd A, Srivanasan J, Horgan G, Hogg D, Myint PK, Newby DE, Williams C, Gray SR, Dawson D. Physical Exercise or Cognitive Behavioral Therapy for Takotsubo Cardiomyopathy: A Randomized Controlled Trial. Circ Heart Fail. 2026 Mar;19(3):e013229. doi: 10.1161/CIRCHEARTFAILURE.125.013229. Epub 2025 Dec 3. |
| D018754 |
| Ventricular Dysfunction |