NCT04666454

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

BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Takotsubo Syndrome

Interventions

Type	Name	Description
DRUG	Adenosine	Adenosine infusion 70 µg/kg/min for 3 hours.
DRUG	Dipyridamole 200 mg	200 mg b.i.d
DRUG	Apixaban 5 mg Oral Tablet	5mg b.i.d
OTHER	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.

Timeline

• Start date: 2020-12-14
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2020-12-14
• Last updated: 2024-12-02

Locations

16 sites across 3 countries: Denmark, Norway, Sweden