BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.
Vastra Gotaland Region
1,000 participants
Dec 14, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria19
- 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
- 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
- Any contra-indication for anticoagulant treatment.
- Current indication for treatment with, anticoagulant or dual antiplatelet therapy
- Declined participation in study 2
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Interventions
Adenosine infusion 70 µg/kg/min for 3 hours.
200 mg b.i.d
5mg b.i.d
This treatment will vary depending on local routines and the degree of adherence to the recommendations.
Locations(16)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04666454