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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04425785
Other study ID # 2-115-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date September 1, 2023

Study information

Verified date December 2023
Source University of Aberdeen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date September 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A patient who has recently suffered an episode of takotsubo cardiomyopathy within the last three weeks - Participant who is willing and able to give informed consent for participation in the study. Exclusion Criteria: - Any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them for taking part in a physical exercise training program. - Any patient who is not able or not 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 (i.e. use of walking aids or prosthetic limbs). - Contraindication to magnetic resonance scanning such as an implantable cardiac device. - Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical Exercise Program
A structured exercise program
Behavioral:
Cognitive Behavioural Therapy
A structured cognitive behavioural therapy program

Locations

Country Name City State
United Kingdom Cardiac Research Facility Aberdeen Aberdeenshire

Sponsors (2)

Lead Sponsor Collaborator
University of Aberdeen British Heart Foundation

Country where clinical trial is conducted

United Kingdom, 

References & Publications (34)

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Chen X, Lee G, Maher BS, Fanous AH, Chen J, Zhao Z, Guo A, van den Oord E, Sullivan PF, Shi J, Levinson DF, Gejman PV, Sanders A, Duan J, Owen MJ, Craddock NJ, O'Donovan MC, Blackman J, Lewis D, Kirov GK, Qin W, Schwab S, Wildenauer D, Chowdari K, Nimgaonkar V, Straub RE, Weinberger DR, O'Neill FA, Walsh D, Bronstein M, Darvasi A, Lencz T, Malhotra AK, Rujescu D, Giegling I, Werge T, Hansen T, Ingason A, Noethen MM, Rietschel M, Cichon S, Djurovic S, Andreassen OA, Cantor RM, Ophoff R, Corvin A, Morris DW, Gill M, Pato CN, Pato MT, Macedo A, Gurling HM, McQuillin A, Pimm J, Hultman C, Lichtenstein P, Sklar P, Purcell SM, Scolnick E, St Clair D, Blackwood DH, Kendler KS; GROUP investigators; International Schizophrenia Consortium. GWA study data mining and independent replication identify cardiomyopathy-associated 5 (CMYA5) as a risk gene for schizophrenia. Mol Psychiatry. 2011 Nov;16(11):1117-29. doi: 10.1038/mp.2010.96. Epub 2010 Sep 14. — View Citation

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Dawson DK, Neil CJ, Henning A, Cameron D, Jagpal B, Bruce M, Horowitz J, Frenneaux MP. Tako-Tsubo Cardiomyopathy: A Heart Stressed Out of Energy? JACC Cardiovasc Imaging. 2015 Aug;8(8):985-7. doi: 10.1016/j.jcmg.2014.10.004. Epub 2014 Nov 1. No abstract available. — View Citation

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Isogai T, Matsui H, Tanaka H, Fushimi K, Yasunaga H. Early beta-blocker use and in-hospital mortality in patients with Takotsubo cardiomyopathy. Heart. 2016 Jul 1;102(13):1029-35. doi: 10.1136/heartjnl-2015-308712. Epub 2016 Feb 15. — View Citation

Kitzman DW, Brubaker PH, Herrington DM, Morgan TM, Stewart KP, Hundley WG, Abdelhamed A, Haykowsky MJ. Effect of endurance exercise training on endothelial function and arterial stiffness in older patients with heart failure and preserved ejection fraction: a randomized, controlled, single-blind trial. J Am Coll Cardiol. 2013 Aug 13;62(7):584-92. doi: 10.1016/j.jacc.2013.04.033. Epub 2013 May 9. — View Citation

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Madhavan M, Prasad A. Proposed Mayo Clinic criteria for the diagnosis of Tako-Tsubo cardiomyopathy and long-term prognosis. Herz. 2010 Jun;35(4):240-3. doi: 10.1007/s00059-010-3339-x. — View Citation

McCalmon SA, Desjardins DM, Ahmad S, Davidoff KS, Snyder CM, Sato K, Ohashi K, Kielbasa OM, Mathew M, Ewen EP, Walsh K, Gavras H, Naya FJ. Modulation of angiotensin II-mediated cardiac remodeling by the MEF2A target gene Xirp2. Circ Res. 2010 Mar 19;106(5):952-60. doi: 10.1161/CIRCRESAHA.109.209007. Epub 2010 Jan 21. — View Citation

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O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454. — View Citation

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Pison L, De Vusser P, Mullens W. Apical ballooning in relatives. Heart. 2004 Dec;90(12):e67. doi: 10.1136/hrt.2004.046813. — View Citation

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. — View Citation

Ridgway N, Williams C. Cognitive behavioural therapy self-help for depression: an overview. J Ment Health. 2011 Dec;20(6):593-603. doi: 10.3109/09638237.2011.613956. — View Citation

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Scally C, Ahearn T, Rudd A, Neil CJ, Srivanasan J, Jagpal B, Horowitz J, Frenneaux M, Dawson DK. Right Ventricular Involvement and Recovery After Acute Stress-Induced (Tako-tsubo) Cardiomyopathy. Am J Cardiol. 2016 Mar 1;117(5):775-80. doi: 10.1016/j.amjcard.2015.11.057. Epub 2015 Dec 13. — View Citation

Scally C, Rudd A, Mezincescu A, Wilson H, Srivanasan J, Horgan G, Broadhurst P, Newby DE, Henning A, Dawson DK. Persistent Long-Term Structural, Functional, and Metabolic Changes After Stress-Induced (Takotsubo) Cardiomyopathy. Circulation. 2018 Mar 6;137(10):1039-1048. doi: 10.1161/CIRCULATIONAHA.117.031841. Epub 2017 Nov 11. — View Citation

Schwarz K, Ahearn T, Srinivasan J, Neil CJ, Scally C, Rudd A, Jagpal B, Frenneaux MP, Pislaru C, Horowitz JD, Dawson DK. Alterations in Cardiac Deformation, Timing of Contraction and Relaxation, and Early Myocardial Fibrosis Accompany the Apparent Recovery of Acute Stress-Induced (Takotsubo) Cardiomyopathy: An End to the Concept of Transience. J Am Soc Echocardiogr. 2017 Aug;30(8):745-755. doi: 10.1016/j.echo.2017.03.016. Epub 2017 Jun 7. — View Citation

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Stiermaier T, Moeller C, Oehler K, Desch S, Graf T, Eitel C, Vonthein R, Schuler G, Thiele H, Eitel I. Long-term excess mortality in takotsubo cardiomyopathy: predictors, causes and clinical consequences. Eur J Heart Fail. 2016 Jun;18(6):650-6. doi: 10.1002/ejhf.494. Epub 2016 Mar 14. — View Citation

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* Note: There are 34 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac Energetics Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy Within three weeks after diagnosis
Primary Cardiac Energetics Cardiac Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy At completion of 12 weeks intervention
Secondary Left Ventricular Global Longitudinal Strain Echocardiography Within three weeks after diagnosis
Secondary Left Ventricular Global Longitudinal Strain Echocardiography At completion of 12 weeks intervention
Secondary Exercise Capacity 6 minute walk test and Cardiopulmonary Exercise Test Within three weeks after diagnosis
Secondary Exercise Capacity 6 minute walk test and Cardiopulmonary Exercise Test At completion of 12 weeks intervention
Secondary Mental status and Stress Index of Mental Wellbeing and Cortisol Awakening Response Within three weeks after diagnosis
Secondary Mental status and Stress Index of Mental Wellbeing and Cortisol Awakening Response At completion of 12 weeks intervention
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