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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Aarhus Universitetshospital
Aarhus, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography)
Time frame: 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%
Time frame: 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
Time frame: up until day 30 respectively 48-96 hours
Randomization 1: The hierarchical occurrence (in descending order of importance) of time to death, time to cardiac assist device, time to cardiac arrest and ejection fraction <50%
Time frame: all time to the first occurrence up until day 30 respectively at 48-96 hours (binary)
Randomization 1: Ejection fraction
Time frame: at 48-96 hours (continuous)
Randomization 1: Any sustained ventricular tachycardia or fibrillation
Time frame: within 48-96 hours (binary)
Randomization 1: Any high-grade atrioventricular block or sinus arrest
Time frame: within 48-96 hours (binary)
Randomization 1: Need for cardiac assist device
Time frame: up until day 30 day (binary)
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This treatment will vary depending on local routines and the degree of adherence to the recommendations.
Oslo University Hospital
Oslo, Norway
RECRUITINGÖstersund Sjukhus
Östersund, Jämtland Härjedalen, Sweden
RECRUITINGRegion Jönköpings Län
Jönköping, Region Jönköping, Sweden
RECRUITINGNorra Älvsborgs länssjukhus
Trollhättan, Västra Götalands Region, Sweden
RECRUITINGRegion Dalarna
Falun, Sweden
RECRUITINGSahlgrenska University Hospital, Department of Cardiology
Gothenburg, Sweden
RECRUITINGSkaraborg Hospital
Gothenburg, Sweden
RECRUITINGRegion Skane Helsingborg Hospital
Helsingborg, Sweden
RECRUITING...and 6 more locations
Randomization 1: Death
Time frame: up until day 30 (binary)
Randomization 1: Stroke
Time frame: up until day 30 (binary)
Randomization 1: Worsening heart failure in hospital (defined as worsening signs or symptoms of heart failure, necessitating intensification of intravenous pharmacologic heart failure therapy or mechanical ventilation)
Time frame: up until day 30
Randomization 2: Presence of cardiac thrombus
Time frame: at 48-96 hours
Randomization 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major
Time frame: up until day 30 (binary)
Randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5
Time frame: up until day 30 (binary)
Randomization 2: BARC grade 3-5
Time frame: up until day 30 (binary)
Randomization 2: Any blood transfusion
Time frame: up until day 30 (binary)