Overview

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

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
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 is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Vastra Gotaland Region
Collaborator:
Sahlgrenska University Hospital, Sweden
Treatments:
Adenosine
Apixaban
Dipyridamole
Criteria
Inclusion Criteria:

1. Age ≥ 18 years.

2. A clinical diagnosis of Takotsubo syndrome (TS)

3. Written informed consent obtained

Exclusion Criteria:

1. Previous randomization in the study

2. Any contra-indication for treatment with adenosine or dipyridamole (including AV-block
II and III, sick sinus syndrome in patients who do not have a functioning pacemaker,
unstable angina, ongoing treatment with dipyridamole)

3. Any concomitant condition resulting in a life expectancy of less than one month

4. Previous myocardial infarction

5. Previously diagnosed left ventricular ejection fraction <50%

6. Known cardiomyopathy

7. Known hemodynamically significant valve disease (moderate or severe aortic/mitral
regurgitation or stenosis)

8. Heart transplant or left ventricular assist device recipient

9. Most recent (within the most recent 3 months) haemoglobin <100 g/L

10. Systolic blood pressure <80 mm Hg at screening

11. Estimated glomerular filtration rate <30 mL/min/1.73m2

12. Current dialysis

13. Pregnancy or of childbearing potential who is not sterilized or is not using a
medically accepted form of contraception

14. 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
study-protocol

Specific subject exclusion criteria (Randomization 2)

1. Any contra-indication for anticoagulant treatment.

2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy.