Heart failure & cardiomyopathies
Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome
Study context
- Population
- Patients with takotsubo syndrome (TS)planned enrolment 1,000
- Planned comparison
- Adenosine and dipyridamole vs standard care (study 1); apixaban vs no antithrombotic drugs (study 2)
- Primary endpoint
- Study 1 coprimary: (1) wall motion score index at 48–96 h (first 200 patients); (2) composite of death, cardiac arrest, mechanical assist device or HF hospitalization within 30 days or LVEF <50% at 48–96 h. Study 2: composite of death or thromboembolic events within 30 days or intraventricular thrombus on echocardiography at 48–96 h
- Follow-up
- 30 days / 48 to 96 hours
Methodological detailsdesign paper, registry-based, 2 × 2 factorial, open-label, parallel, multicentre
- Design paper
- Registry-based
- 2 × 2 factorial
- Open-label
- Parallel
- Multicentre
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome. Am Heart J. Published 23 November 2022. doi:10.
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