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

Launched by VASTRA GOTALAND REGION · Dec 7, 2020

Keywords

ClinConnect Summary

The BROKEN-SWEDEHEART trial is studying a new treatment approach for Takotsubo Syndrome, often called "broken heart syndrome." This condition can happen after a stressful event, leading to temporary heart muscle weakness. The goal of the study is to find the best medications to help patients recover. The trial will include 1,000 patients who have been diagnosed with this syndrome and have a specific heart function measurement called ejection fraction that is below 50%.

To participate, individuals must be at least 18 years old and have a recent diagnosis of Takotsubo Syndrome. However, there are some criteria that might prevent someone from joining, such as having other serious heart conditions or health issues that could affect their treatment. If eligible, participants will receive treatment and be monitored to see how well the new medications work. It's important to note that the trial is currently recruiting participants, so there is an opportunity for eligible patients to contribute to this important research.

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Eligibility criteria

• 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