BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
NCT ID: NCT04666454
Last Updated: 2024-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1000 participants
INTERVENTIONAL
2020-12-14
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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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.
Adenosine
Adenosine infusion 70 µg/kg/min for 3 hours.
Dipyridamole 200 mg
200 mg b.i.d
Randomisation 1: Control
Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology.
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.
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.
Apixaban 5 mg Oral Tablet
5mg b.i.d
Randomisation 2: No anticoagulant therapy
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
3. Written informed consent obtained
Exclusion Criteria
2. Any concomitant condition resulting in a life expectancy of less than one month
3. Previously diagnosed left ventricular ejection fraction \<50%
4. Known cardiomyopathy (except previous Takotsubo syndrome)
5. Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
6. Heart transplant or left ventricular assist device recipient
7. Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
8. Systolic blood pressure \<80 mm Hg at screening
9. Estimated glomerular filtration rate \<30 mL/min/1.73m2
10. Current dialysis
11. Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
12. Not suitable in the opinion of the investigator due to severe or terminal comorbidity with poor prognosis, or characteristics that may interfere with adherence to the trial protocol
13. Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick-sinus syndrome in subjects who don´t have a functioning pacemaker, unstable angina, ongoing treatment with dipyridamole)
14. Severe asthma (defined as asthma requiring medium or high-dose inhaled corticosteroids combined with other long-acting medications) and severe Chronic Obstructive Pulmonary Disease (COPD), (defined as FEV-1 ˂ 50 %)
15. Ongoing treatment with dipyridamole
16. Declined participation in study 1
1. Any contra-indication for anticoagulant treatment.
2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy
3. Declined participation in study 2
18 Years
ALL
No
Sponsors
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Göteborg University
OTHER
Vastra Gotaland Region
OTHER_GOV
Responsible Party
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Principal Investigators
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Elmir Omerovic, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Sahlgrenska University Hospital
Locations
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Aarhus Universitetshospital
Aarhus, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Oslo University Hospital
Oslo, , Norway
Östersund Sjukhus
Östersund, Jämtland Härjedalen, Sweden
Region Jönköpings Län
Jönköping, Region Jönköping, Sweden
Norra Älvsborgs länssjukhus
Trollhättan, Västra Götalands Region, Sweden
Region Dalarna
Falun, , Sweden
Sahlgrenska University Hospital, Department of Cardiology
Gothenburg, , Sweden
Skaraborg Hospital
Gothenburg, , Sweden
Region Skane Helsingborg Hospital
Helsingborg, , Sweden
Region Oestergoetland
Linköping, , Sweden
Region Skane - Skanes Universitetssjukhus
Lund, , Sweden
Region Orebro lan
Örebro, , Sweden
Danderyds Hospital, Department of Cardiology
Stockholm, , Sweden
Karolinska University Hospital, Huddinge, Department of Cardiology
Stockholm, , Sweden
Umeå University Hospital, Department of Cardiology
Umeå, , Sweden
Countries
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Central Contacts
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Björn Redfors, MD, PhD
Role: CONTACT
Facility Contacts
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Steen Hvitfeldt Poulsen, MD
Role: primary
Lia Evi Bang, MD
Role: primary
Njord Nordstrand, MD
Role: primary
Per Lundberg, MD
Role: primary
Lisa Brandin, MD
Role: primary
Sven-Erik Olsson, MD
Role: primary
Joakim Alfredsson, MD
Role: primary
Nazim Isma, MD
Role: primary
Anna Nordenskjöld, MD
Role: primary
Christina Ekenbäck, MD
Role: primary
Loghman Henareh, MD
Role: primary
Henrik Hagström, MD
Role: primary
References
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Omerovic E, James S, Erlinge D, Hagstrom H, Venetsanos D, Henareh L, Ekenback C, Alfredsson J, Hambreus K, Redfors B. Rationale and design of BROKEN-SWEDEHEART: a registry-based, randomized, parallel, open-label multicenter trial to test pharmacological treatments for broken heart (takotsubo) syndrome. Am Heart J. 2023 Mar;257:33-40. doi: 10.1016/j.ahj.2022.11.010. Epub 2022 Nov 23.
Other Identifiers
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BROKEN SWEDEHEART
Identifier Type: -
Identifier Source: org_study_id