BROKEN-SWEDEHEART-Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome

  • STATUS
    Recruiting
  • End date
    Dec 22, 2024
  • participants needed
    1000
  • sponsor
    Vastra Gotaland Region
Updated on 22 March 2022

Summary

The aim of this study is to document an optimized pharmacologic treatment for patients with Takotsubo Syndrome. There is currently no published documentation in a large number of patients. The study is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.

Details
Condition Takotsubo Syndrome
Treatment Adenosine, Dipyridamole 200 mg, Dipyridamole 200 mg, Apixaban 5 mg Oral Tablet, Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome
Clinical Study IdentifierNCT04666454
SponsorVastra Gotaland Region
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
A clinical diagnosis of Takotsubo syndrome (TS)
Written informed consent obtained

Exclusion Criteria

Previous randomization in the study
Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick sinus syndrome in patients who do not have a functioning pacemaker, unstable angina, ongoing treatment with dipyridamole)
Any concomitant condition resulting in a life expectancy of less than one month
Previous myocardial infarction
Previously diagnosed left ventricular ejection fraction <50%
Known cardiomyopathy
Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation or stenosis)
Heart transplant or left ventricular assist device recipient
Most recent (within the most recent 3 months) haemoglobin <100 g/L
Systolic blood pressure <80 mm Hg at screening
Estimated glomerular filtration rate <30 mL/min/1.73m2
Current dialysis
Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to the study-protocol
Specific subject exclusion criteria (Randomization 2)
Any contra-indication for anticoagulant treatment
Current indication for treatment with, anticoagulant or dual antiplatelet therapy
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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