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Optimized pharmacologic treatment for broken heart (takotsubo) syndrome
EU CTIS ID: 2022-501874-21-00
What this study is testing
The objective of the study is to investigate whether treatment with: (i) adenosine and the adenosine reuptake inhibitor dipyridamole improves clinical outcomes in patients with Takotsubo Syndrome compared to standard of care (according to current recommendations from ESC taskforce for Takotsubo Syndrome (Randomization 1) To test whether treatment with apixaban reduces the risk of thromboembolic events compared to no treatment with antithrombotic drugs (Randomization 2)
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age equal or above 18 years
- 2. A clinical diagnosis of Takotsubo Syndrome, including an ejection fraction (EF) <50% at baseline
- 3. Written informed consent obtained
You likely can't join if
- Previous randomization in the study
- Previously diagnosed left ventrilular ejaction fraction lower than 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 moths) haemoglobin lower than 100 g/L
See the full eligibility criteria
- 1. Age equal or above 18 years
- 2. A clinical diagnosis of Takotsubo Syndrome, including an ejection fraction (EF) <50% at baseline
- 3. Written informed consent obtained
- Previous randomization in the study
- Previously diagnosed left ventrilular ejaction fraction lower than 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 moths) haemoglobin lower than 100 g/L
- Any concomitant condition resulting in a life expectancy of less than one month
- Systolic blood pressure lower than 80 mm Hg at screening
- Estimated glomerular filtration rate lower than 30 mL/min/1.73 m2
- Current dialysis
- Pregnancy or of childbearing potential who is not steralized 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 study-protocol
- Specific exclusion criteria for randomization 2 as following: 1.Any contra-indication for anticoagulant treatment. 2.Current indication for treatment with, anticoagulant or dual antiplatelet therapy 3.Declined participation in study 2.
- Specific exclusion criteria for randomization 1 as following: 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) 2. 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 %) 3. Ongoing treatment with dipyridamole. 4 Declined participation in study 1.
- Any concomitant condition resulting in a life expectancy of less than one month
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.