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BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.

RecruitingPhase 4Ages 18 Years - anyAllVastra Gotaland Region
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age ≥ 18 years. 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: 1. Previous randomization in the trial 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 Specific exclusion criteria for Randomization 1 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 Specific exclusion criteria for Randomization 2 1. Any contra-indication for anticoagulant treatment. 2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy 3. Declined participation in study 2
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What it tests

  • Adenosine
  • Dipyridamole 200 mg
  • Apixaban 5 mg Oral Tablet
  • Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome
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Where

16 sites
Aarhus Universitetshospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Oslo University Hospital
Oslo, Norway
Östersund Sjukhus
Östersund, Sweden
Region Jönköpings Län
Jönköping, Sweden
Norra Älvsborgs länssjukhus
Trollhättan, Sweden
Region Dalarna
Falun, Sweden
Sahlgrenska University Hospital, Department of Cardiology
Gothenburg, Sweden

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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