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Optimized pharmacological treatment for broken heart (takotsubo) syndrome

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501874-21-00
Acronym
BROKEN-SWEDEHEART
Enrollment
1600
Registered
2022-11-18
Start date
2020-12-15
Completion date
Unknown
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Takotsubo syndrome

Brief summary

Randomization 1: First co-primary endpoint - Wall motion score index at 48-96 hors, Randomization 1: Second co-primary endpoint- The occurrence of the composite of death, cardiac arrest,or the need for cardiac mechanicalassist device up until day 30,or ejaction fraction less than 50% at 48-96 hours or rehospitalization for heart failure up until day 30, Randomization 2:The occurrence of any thromboembolic event(defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death up until day 30,or the presence of a cardiac thrombus at 48-96 hours as assessed by echocardiography

Detailed description

The hierarchical occurrence of time to death, time to cardiac assist device, time to cardiac arrest (all time to the first occurance up until day 30), and ejaction fraction less than 50% at 48-96 hours (binary), Ejaction fraction at 48-96 hours (continuous), Any sustained ventricular tachycardia or fibrillation within 48-96 hours (binary), Any high-grade atrioventricular block or sinus arrest within 48-96 hours (binary), Need for cardiac assist device up until day 30 (binary), Death up until day 30 (binary), Stroke up until day 30 (binary), Rehospitalization for Takotsubo Syndrome at 6 months and 1-10 years, All cause mortality at 6 months and 1-10 years, Worsening heart failure in hospital up until day 30, Specific for randomization 2: cardiac thrombus at 48 - 96 hrs, Specific for randomization 2: thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major up until 30 days (binary), Specific for randomization 2: ejection fraction (EF) < 50% at 48 - 96 hrs (binary), Specific for randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5 up until 30 days (binary), Specific for randomization 2: any blood transfusion (binary)

Interventions

DRUGDipyridamol Alternova 200 mg depotkapslar
DRUGhårda

Sponsors

Vastra Gotalandsregionen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Randomization 1: First co-primary endpoint - Wall motion score index at 48-96 hors, Randomization 1: Second co-primary endpoint- The occurrence of the composite of death, cardiac arrest,or the need for cardiac mechanicalassist device up until day 30,or ejaction fraction less than 50% at 48-96 hours or rehospitalization for heart failure up until day 30, Randomization 2:The occurrence of any thromboembolic event(defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death up until day 30,or the presence of a cardiac thrombus at 48-96 hours as assessed by echocardiography

Secondary

MeasureTime frame
The hierarchical occurrence of time to death, time to cardiac assist device, time to cardiac arrest (all time to the first occurance up until day 30), and ejaction fraction less than 50% at 48-96 hours (binary), Ejaction fraction at 48-96 hours (continuous), Any sustained ventricular tachycardia or fibrillation within 48-96 hours (binary), Any high-grade atrioventricular block or sinus arrest within 48-96 hours (binary), Need for cardiac assist device up until day 30 (binary), Death up until day 30 (binary), Stroke up until day 30 (binary), Rehospitalization for Takotsubo Syndrome at 6 months and 1-10 years, All cause mortality at 6 months and 1-10 years, Worsening heart failure in hospital up until day 30, Specific for randomization 2: cardiac thrombus at 48 - 96 hrs, Specific for randomization 2: thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major up until 30 days (binary), Specific for randomization 2: ejection fraction (EF) < 50% at 48 - 96 hrs (binary), S

Countries

Denmark, Norway, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026