Status:
RECRUITING
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
Göteborg University
Conditions:
Takotsubo Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 i...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
- Written informed consent obtained
Exclusion
- 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
- Any contra-indication for anticoagulant treatment.
- Current indication for treatment with, anticoagulant or dual antiplatelet therapy
- Declined participation in study 2
Key Trial Info
Start Date :
December 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04666454
Start Date
December 14 2020
End Date
December 1 2028
Last Update
December 2 2024
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Aarhus Universitetshospital
Aarhus, Denmark
2
Rigshospitalet
Copenhagen, Denmark
3
Oslo University Hospital
Oslo, Norway
4
Östersund Sjukhus
Östersund, Jämtland Härjedalen, Sweden, 831 27