BridgeMD
New treatment option for Takotsubo Syndrome
Official title BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
ClinicalTrials.gov ID: NCT04666454
What this study is testing
What is Adenosine?
Adenosine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for takotsubo syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years.
- A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
- Written informed consent obtained
You likely can't join if
- 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
See the full eligibility criteria
- Age ≥ 18 years.
- A clinical diagnosis of TS (see definition 2.1), including an ejection fraction (EF) ˂ 50 % at baseline
- Written informed consent obtained
- 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...
- Any contra-indication for treatment with adenosine or dipyridamole (including AV-block II and III, sick-sinus syndrome in people who don´t have a functioning pacemaker, unstable angina, ongoing treatment with...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Oslo, Norway
- Östersund, Jämtland Härjedalen, Sweden
- Jönköping, Region Jönköping, Sweden
- Trollhättan, Västra Götalands Region, Sweden
- Falun, Sweden
- Gothenburg, Sweden
- Helsingborg, Sweden
- Linköping, Sweden
- Lund, Sweden
- Örebro, Sweden
- Stockholm, Sweden
- Umeå, Sweden
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Copenhagen, Denmark; Oslo, Norway; Östersund, Jämtland Härjedalen, Sweden; Jönköping, Region Jönköping, Sweden; Trollhättan, Västra Götalands Region, Sweden and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.