Takotsubo Syndrome
Conditions
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 is a Randomized Registry Clinical Trial and in total 1000 patients registered in SWEDEHEART will be included.
Interventions
DRUGAdenosine
Adenosine infusion 70 µg/kg/min for 3 hours.
DRUGDipyridamole 200 mg
200 mg b.i.d
5mg b.i.d
OTHERCare as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome
This treatment will vary depending on local routines and the degree of adherence to the recommendations.
Sponsors
Göteborg University
Vastra Gotaland Region
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multinational, Multicentre, registry-based, open-label, randomized controlled trial with 2 × 2 factorial design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography) | 48-96 hours |
| Randomization 1: Second co-primary endpoint: The occurrence of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device, or re-hospitalization for heart failure or ejection fraction <50% | up until day 30 day respectively at 48-96 hours |
| Randomization 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death, or the presence of a cardiac thrombus, as assessed by echocardiography | up until day 30 respectively 48-96 hours |
Secondary
| Measure | Time frame |
|---|---|
| Randomization 1: Any high-grade atrioventricular block or sinus arrest | within 48-96 hours (binary) |
| Randomization 1: Need for cardiac assist device | up until day 30 day (binary) |
| Randomization 1: Death | up until day 30 (binary) |
| Randomization 1: Stroke | up until day 30 (binary) |
| Randomization 1: Worsening heart failure in hospital (defined as worsening signs or symptoms of heart failure, necessitating intensification of intravenous pharmacologic heart failure therapy or mechanical ventilation) | up until day 30 |
| Randomization 1: The hierarchical occurrence (in descending order of importance) of time to death, time to cardiac assist device, time to cardiac arrest and ejection fraction <50% | all time to the first occurrence up until day 30 respectively at 48-96 hours (binary) |
| Randomization 2: Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria minor or major | up until day 30 (binary) |
| Randomization 2: Bleeding Academic Research Consortium (BARC) grade 2-5 | up until day 30 (binary) |
| Randomization 2: BARC grade 3-5 | up until day 30 (binary) |
| Randomization 2: Any blood transfusion | up until day 30 (binary) |
| Randomization 2: Presence of cardiac thrombus | at 48-96 hours |
| Randomization 1: Ejection fraction | at 48-96 hours (continuous) |
| Randomization 1: Any sustained ventricular tachycardia or fibrillation | within 48-96 hours (binary) |
Countries
Denmark, Norway, Sweden
Contacts
Primary ContactElmir Omerovic, MD PhD
Backup ContactBjörn Redfors, MD, PhD
Outcome results
None listed