Optimized treatment for Takotsubo Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to document an optimized pharmacologic treatment for patients diagnosed with Takotsubo Syndrome, a condition characterized by temporary heart muscle failure. It is a randomized registry clinical trial that will include 1000 patients registered in the SWEDEHEART database. Participants will receive treatments such as Adenosine, Dipyridamole, and Apixaban, alongside care recommended by the European Society of Cardiology's Taskforce on Takotsubo Syndrome. The study seeks to establish effective treatment protocols for this under-researched condition.

Why it matters

Who can join: the full rules

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

Where it's running

• Aarhus Universitetshospital
  Aarhus, Denmark Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Oslo University Hospital
  Oslo, Norway Recruiting
• Östersund Sjukhus
  Östersund, Jämtland Härjedalen, Sweden Recruiting
• Region Jönköpings Län
  Jönköping, Region Jönköping, Sweden Recruiting
• Norra Älvsborgs länssjukhus
  Trollhättan, Västra Götalands Region, Sweden Recruiting

Study contacts

• Principal investigator: Elmir Omerovic, MD PhD — Sahlgrenska University Hospital
• Study coordinator: Elmir Omerovic, MD PhD
• Email: elmir@wlab.gu.se
• Phone: 31 3421000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating the link between Takotsubo Syndrome and air pollution

  This study is trying to see if air pollution is linked to Takotsubo Syndrome, a heart condition that can be triggered by stress or illness, to help understand how to prevent it better.

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• Registry for patients with Takotsubo Syndrome in Poland

  This study is collecting information from people in Poland with Takotsubo Syndrome to learn more about the condition and how to improve care for it.

  Recruiting Medical University of Warsaw · Warsaw · NCT04634487

• Registry of patients with Takotsubo syndrome

  This study collects detailed information about people with Takotsubo syndrome to better understand their experiences and health outcomes over time.

  Recruiting at 2 sites University of Luebeck · Lübeck, Schleswig-Holstein and 1 other locations · NCT04361994

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.