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
|Condition or disease||Intervention/treatment|
|Tako-tsubo Cardiomyopathy||Other: Assessment of exercise capacity and cardiac energetics|
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:
- 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
- Physical deconditioning after an acute, severe illness.
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|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|
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
- Cardiac energetics by cardiac magnetic resonance imaging [ Time Frame: One year or longer after diagnosis ]Cardiac magnetic resonance imaging and spectroscopy
- Exercise capacity [ Time Frame: One year or longer after diagnosis ]Cardiopulmonary exercise testing
Biospecimen Retention: Samples With DNA
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
|Cardiac Research Office, Aberdeen Royal Infirmary|
|Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZD|
|Principal Investigator:||Dana Dawson, PhD||University of Aberdeen|