BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.
Who is this study for? Patients with Takotsubo Syndrome
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years.
• A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
• Written informed consent obtained
Locations
Other Locations
Denmark
Aarhus Universitetshospital
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Norway
Oslo University Hospital
RECRUITING
Oslo
Sweden
Region Dalarna
RECRUITING
Falun
Sahlgrenska University Hospital, Department of Cardiology
RECRUITING
Gothenburg
Skaraborg Hospital
RECRUITING
Gothenburg
Region Skane Helsingborg Hospital
RECRUITING
Helsingborg
Region Jönköpings Län
RECRUITING
Jönköping
Region Oestergoetland
RECRUITING
Linköping
Region Skane - Skanes Universitetssjukhus
RECRUITING
Lund
Region Orebro lan
RECRUITING
Örebro
Östersund Sjukhus
RECRUITING
Östersund
Danderyds Hospital, Department of Cardiology
RECRUITING
Stockholm
Karolinska University Hospital, Huddinge, Department of Cardiology
RECRUITING
Stockholm
Norra Älvsborgs länssjukhus
RECRUITING
Trollhättan
Umeå University Hospital, Department of Cardiology
RECRUITING
Umeå
Contact Information
Primary
Elmir Omerovic, MD PhD
elmir@wlab.gu.se
31 3421000
Backup
Björn Redfors, MD, PhD
31 3421000
Time Frame
Start Date: 2020-12-14
Estimated Completion Date: 2028-12
Participants
Target number of participants: 1000
Treatments
Active_comparator: Randomisation 1: Adenosine and Dipyridamole
Adenosine infusion 70 µg/kg/min for 3 hours, followed (first dose 60 minutes apart from the end of the adenosine infusion) by daily oral treatment with the adenosine reuptake inhibitor dipyridamole (200 mg b.i.d.) until normalization of Left Ventricular (LV) function (EF≥50%) is documented on the study-specific echocardiographic assessment at 48-96 hours or at any subsequent echocardiographic examination, or for 30+7 Days.
Other: Randomisation 1: Control
Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.
Active_comparator: Randomisation 2: Apixaban
Apixaban 5mg b.i.d. per oral until normalization of LV function (EF≥50%) is documented on the study-specific echocardiographic assessment at 48-96 hours or any subsequent echocardiographic examination, or for 30+7 Days.
No_intervention: Randomisation 2: No anticoagulant therapy
Related Therapeutic Areas
Sponsors
Leads: Vastra Gotaland Region
Collaborators: Göteborg University