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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Randomisation 1: Adenosine and Dipyridamole | Active Comparator | 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. |
|
| Randomisation 1: Control | Other | Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology. |
|
| Randomisation 2: Apixaban | Active Comparator | 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. |
|
| Randomisation 2: No anticoagulant therapy | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adenosine | Drug | Adenosine infusion 70 µg/kg/min for 3 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography) | 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% | 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 | up until day 30 respectively 48-96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | all time to the first occurrence up until day 30 respectively at 48-96 hours (binary) | |
| Randomization 1: Ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
Previous randomization in the trial
Any concomitant condition resulting in a life expectancy of less than one month
Previously diagnosed left ventricular ejection fraction <50%
Known cardiomyopathy (except previous Takotsubo syndrome)
Known hemodynamically significant valve disease (moderate or severe aortic/mitral regurgitation) or stenosis
Heart transplant or left ventricular assist device recipient
Most recent (within the most recent 3 months) haemoglobin ˂10 g/dL
Systolic blood pressure <80 mm Hg at screening
Estimated glomerular filtration rate <30 mL/min/1.73m2
Current dialysis
Pregnancy or of childbearing potential who is not sterilized or is not using a medically accepted form of contraception
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
Specific exclusion criteria for Randomization 1
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)
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 %)
Ongoing treatment with dipyridamole
Declined participation in study 1
Specific exclusion criteria for Randomization 2
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elmir Omerovic, MD PhD | Contact | 31 3421000 | +46 | elmir@wlab.gu.se |
| Björn Redfors, MD, PhD | Contact | 31 3421000 | +46 |
| Name | Affiliation | Role |
|---|---|---|
| Elmir Omerovic, MD PhD | Sahlgrenska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus Universitetshospital | Recruiting | Aarhus | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36435233 | Derived | 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. |
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To be decided.
To be decided
To be decided (TBD)
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Multinational, Multicentre, registry-based, open-label, randomized controlled trial with 2 × 2 factorial design
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| Dipyridamole 200 mg | Drug | 200 mg b.i.d |
|
| Apixaban 5 mg Oral Tablet | Drug | 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 | Other | This treatment will vary depending on local routines and the degree of adherence to the recommendations. |
|
| at 48-96 hours (continuous) |
| Randomization 1: Any sustained ventricular tachycardia or fibrillation | within 48-96 hours (binary) |
| Randomization 1: Any high-grade atrioventricular block or sinus arrest | within 48-96 hours (binary) |
| Randomization 1: Need for cardiac assist device | up until day 30 day (binary) |
| Randomization 1: Death | up until day 30 (binary) |
| Randomization 1: Stroke | 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) | up until day 30 |
| Randomization 2: Presence of cardiac thrombus | at 48-96 hours |
| Randomization 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major | up until day 30 (binary) |
| Randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5 | up until day 30 (binary) |
| Randomization 2: BARC grade 3-5 | up until day 30 (binary) |
| Randomization 2: Any blood transfusion | up until day 30 (binary) |
| Rigshospitalet | Recruiting | Copenhagen | Denmark |
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| Oslo University Hospital | Recruiting | Oslo | Norway |
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| Östersund Sjukhus | Recruiting | Östersund | Jämtland Härjedalen | 831 27 | Sweden |
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| Region Jönköpings Län | Recruiting | Jönköping | Region Jönköping | 55111 | Sweden |
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| Norra Älvsborgs länssjukhus | Recruiting | Trollhättan | Västra Götalands Region | 46173 | Sweden |
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| Region Dalarna | Recruiting | Falun | Sweden |
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| Sahlgrenska University Hospital, Department of Cardiology | Recruiting | Gothenburg | Sweden |
| Skaraborg Hospital | Recruiting | Gothenburg | Sweden |
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| Region Skane Helsingborg Hospital | Recruiting | Helsingborg | Sweden |
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| Region Oestergoetland | Recruiting | Linköping | Sweden |
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| Region Skane - Skanes Universitetssjukhus | Recruiting | Lund | Sweden |
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| Region Orebro lan | Recruiting | Örebro | Sweden |
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| Danderyds Hospital, Department of Cardiology | Recruiting | Stockholm | Sweden |
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| Karolinska University Hospital, Huddinge, Department of Cardiology | Recruiting | Stockholm | Sweden |
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| Umeå University Hospital, Department of Cardiology | Recruiting | Umeå | Sweden |
|
| ID | Term |
|---|---|
| D054549 | Takotsubo Cardiomyopathy |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018487 | Ventricular Dysfunction, Left |
| D018754 | Ventricular Dysfunction |
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| ID | Term |
|---|---|
| D000241 | Adenosine |
| D004176 | Dipyridamole |
| C522181 | apixaban |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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