BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
Condition(s) studied
Investigational drug(s) / intervention(s)
Adenosine: Adenosine infusion 70 µg/kg/min for 3 hours.
Dipyridamole 200 mg: 200 mg b.i.d
Apixaban 5 mg Oral Tablet: 5mg b.i.d
Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome: This treatment will vary depending on local routines and the degree of adherence to the recommendations.
Study 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.
Eligibility
Primary outcome measure(s)
- Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography) — 48-96 hours
- Randomization 1: Second co-primary endpoint: The occurrence of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device, or re-hospitalization for heart failure or ejection fraction <50% — up until day 30 day respectively at 48-96 hours
- Randomization 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death, or the presence of a cardiac thrombus, as assessed by echocardiography — up until day 30 respectively 48-96 hours
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| Aarhus Universitetshospital | Aarhus | Denmark | Recruiting |
| Rigshospitalet | Copenhagen | Denmark | Recruiting |
| Oslo University Hospital | Oslo | Norway | Recruiting |
| Östersund Sjukhus | Östersund | Jämtland Härjedalen | Recruiting |
| Region Jönköpings Län | Jönköping | Region Jönköping | Recruiting |
| Norra Älvsborgs länssjukhus | Trollhättan | Västra Götalands Region | Recruiting |
| Region Dalarna | Falun | Sweden | Recruiting |
| Sahlgrenska University Hospital, Department of Cardiology | Gothenburg | Sweden | Recruiting |
| Skaraborg Hospital | Gothenburg | Sweden | Recruiting |
| Region Skane Helsingborg Hospital | Helsingborg | Sweden | Recruiting |
| Region Oestergoetland | Linköping | Sweden | Recruiting |
| Region Skane - Skanes Universitetssjukhus | Lund | Sweden | Recruiting |
| Region Orebro lan | Örebro | Sweden | Recruiting |
| Danderyds Hospital, Department of Cardiology | Stockholm | Sweden | Recruiting |
| Karolinska University Hospital, Huddinge, Department of Cardiology | Stockholm | Sweden | Recruiting |
| Umeå University Hospital, Department of Cardiology | Umeå | Sweden | Recruiting |
More Vastra Gotaland Region trials in Sweden
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04666454 on ClinicalTrials.gov ↗ ← All trials in Sweden