BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
ConditionTakotsubo Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
Written informed consent obtained
Disqualifiers
Previous randomization in the trial
Any concomitant condition resulting in a life expectancy of less than one month
Previously diagnosed left ventricular ejection fraction <50%
Known cardiomyopathy (except previous Takotsubo syndrome)
Trial design
Treatments tested in this trial
- Adenosine
- 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
Treatment groups
1,000 Participants
are divided into 4 treatment groupsLocations
16Denmark
Aarhus Universitetshospital Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Norway
Oslo University Hospital Oslo Norway
Sweden
Östersund Sjukhus831 27, ÖstersundJämtland Härjedalen, Sweden
Sponsors and collaborators
Vastra Gotaland Region
Lead sponsor
Göteborg University
Collaborator
Source ClinicalTrials.gov