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Persistent Symptoms and Early Incomplete Recovery After Acute Stress-induced Cardiomyopathy: Is There Ongoing Heart Distress? The HEROIC Study (HEROIC)

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ClinicalTrials.gov Identifier: NCT02989454
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : May 8, 2019
Sponsor:
Collaborator:
NHS Grampian
Information provided by (Responsible Party):
University of Aberdeen

Brief Summary:
Acute stress induced (Tako-tsubo) cardiomyopathy (TTC) or broken heart syndrome, a condition typically occurring after acute stress has a death rate similar to heart attacks and is frequently associated with long-term symptoms (fatigue and exercise limitation). There are no effective therapies. The investigators have recently showed that there is a profound shortage of energy in the hearts of Tako Tsubo Cardiomyopathy patients in the days after acute presentation with only partial recovery by four months. The investigators would now like to establish whether this recovers after at least one year, or persists, and also to investigate the mechanisms responsible for exercise limitation after recovery from the acute phase.

Condition or disease Intervention/treatment
Tako-tsubo Cardiomyopathy Other: Assessment of exercise capacity and cardiac energetics

Detailed Description:

Tako Tsubo Cardiomyopathy presents with sudden onset of chest pain that mimics a myocardial infarction (MI) and is precipitated by major emotional/physical stress. Classically, the coronary arteries are normal and yet, the left ventricular (LV) angiogram shows a characteristic, extensive and severe wall motion abnormality, some develop cardiogenic shock, cardiac rupture or embolic stroke. In the weeks following onset, the wall motion abnormalities gradually recover: this led to the assumption that Tako Tsubo Cardiomyopathy is self-limiting, reinforced by the absence of myocardial damage on cardiac Magnetic Resonance Imaging. However, the investigators and others have shown that Tako Tsubo Cardiomyopathy recovery is not rapid, being characterised by severe global oedema, which persists for 3-4 months after presentation. The investigators showed profound decrease in cardiac energetics during the acute Tako Tsubo Cardiomyopathy phase compared to healthy controls. This improved significantly at follow up but remained reduced compared to healthy controls.

These objective findings of incompletely resolved myocardial oedema and energetic impairment are in contrast with the more rapid apparent recovery of Left Ventricular Ejection Fraction but are in keeping with the persistence of symptoms previously reported in literature and with the investigators' own clinical observations from the Tako Tsubo Cardiomyopathy follow-up clinic at the institution.

The persistence of symptoms (fatigue, recurrent chest pains, decreased exercise capacity) could be due to either:

  1. Subclinical degree of impairment in cardiac energetics/function (reflecting either an even more prolonged status of incomplete recovery or a pre-existent cardiomyopathy) which despite a normalised for almost normalised ejection fraction at rest results in cardiac limitation during exercise, or
  2. Physical deconditioning after an acute, severe illness.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Persistent Symptoms and Early Incomplete Recovery After Acute Stress-induced Cardiomyopathy: Is There Ongoing Heart Distress? The HEROIC Study
Study Start Date : August 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017


Group/Cohort Intervention/treatment
Tako Tsubo Cardiomyopathy patients
Any patient who has suffered from Tako Tsubo Cardiomyopathy since 2011.
Other: Assessment of exercise capacity and cardiac energetics
Cardiopulmonary exercise testing and Magnetic Resonance Spectroscopy
Other Name: MRI, MRS and CPEX




Primary Outcome Measures :
  1. Cardiac energetics by cardiac magnetic resonance imaging [ Time Frame: One year or longer after diagnosis ]
    Cardiac magnetic resonance imaging and spectroscopy


Secondary Outcome Measures :
  1. Exercise capacity [ Time Frame: One year or longer after diagnosis ]
    Cardiopulmonary exercise testing


Biospecimen Retention:   Samples With DNA
Samples for genetic analysis will be stored.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Any patient that has been diagnosed with Tako Tsubo Cardiomyopathy since 2011.
Criteria

Inclusion Criteria:

  • Any patient diagnosed with Tako Tsubo Cardiomyopathy in Aberdeen, Glasgow and Inverness since 2011.

Exclusion Criteria:

  • Contraindication to magnetic resonance scanning such as an implantable cardiac device, etc for those undergoing magnetic resonance imaging only (they can attend for cardiopulmonary exercise testing and bloods).
  • Inability to exercise on a treadmill (they can attend for magnetic resonance imaging and bloods).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989454


Locations
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United Kingdom
Cardiac Research Office, Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD
Sponsors and Collaborators
University of Aberdeen
NHS Grampian
Investigators
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Principal Investigator: Dana Dawson, PhD University of Aberdeen

Publications:
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, Nöethen 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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Aberdeen
ClinicalTrials.gov Identifier: NCT02989454     History of Changes
Other Study ID Numbers: 2/005/15
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiomyopathies
Takotsubo Cardiomyopathy
Heart Diseases
Cardiovascular Diseases
Ventricular Dysfunction, Left
Ventricular Dysfunction