Actively Recruiting
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
Led by Vastra Gotaland Region · Updated on 2024-12-02
1000
Participants Needed
16
Research Sites
415 weeks
Total Duration
On this page
Sponsors
V
Vastra Gotaland Region
Lead Sponsor
G
Göteborg University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of Takotsubo Syndrome with ejection fraction 50% or higher at baseline
- Written informed consent obtained
You will not qualify if you...
- Previous randomization in this trial
- Any condition with life expectancy less than one month
- Previously diagnosed left ventricular ejection fraction below 50%
- Known cardiomyopathy except prior Takotsubo Syndrome
- Moderate or severe aortic/mitral valve disease or stenosis
- Heart transplant or left ventricular assist device recipient
- Hemoglobin 10 g/dL or less within the past 3 months
- Systolic blood pressure below 80 mm Hg at screening
- Estimated glomerular filtration rate below 30 mL/min/1.73m2
- Currently on dialysis
- Pregnancy or childbearing potential without sterilization or contraception
- Investigator opinion of unsuitability due to severe or terminal comorbidity or factors affecting protocol adherence
- Contraindications to adenosine or dipyridamole (e.g., AV-block II/III, sick-sinus syndrome without pacemaker, unstable angina)
- Severe asthma requiring medium/high-dose inhaled corticosteroids with other meds or severe COPD (FEV-1 ≤ 50%)
- Ongoing treatment with dipyridamole
- Declined participation in randomization 1
- Contraindications for anticoagulant treatment
- Current indication for anticoagulant or dual antiplatelet therapy
- Declined participation in randomization 2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Aarhus Universitetshospital
Aarhus, Denmark
Actively Recruiting
2
Rigshospitalet
Copenhagen, Denmark
Actively Recruiting
3
Oslo University Hospital
Oslo, Norway
Actively Recruiting
4
Östersund Sjukhus
Östersund, Jämtland Härjedalen, Sweden, 831 27
Actively Recruiting
5
Region Jönköpings Län
Jönköping, Region Jönköping, Sweden, 55111
Actively Recruiting
6
Norra Älvsborgs länssjukhus
Trollhättan, Västra Götalands Region, Sweden, 46173
Actively Recruiting
7
Region Dalarna
Falun, Sweden
Actively Recruiting
8
Sahlgrenska University Hospital, Department of Cardiology
Gothenburg, Sweden
Actively Recruiting
9
Skaraborg Hospital
Gothenburg, Sweden
Actively Recruiting
10
Region Skane Helsingborg Hospital
Helsingborg, Sweden
Actively Recruiting
11
Region Oestergoetland
Linköping, Sweden
Actively Recruiting
12
Region Skane - Skanes Universitetssjukhus
Lund, Sweden
Actively Recruiting
13
Region Orebro lan
Örebro, Sweden
Actively Recruiting
14
Danderyds Hospital, Department of Cardiology
Stockholm, Sweden
Actively Recruiting
15
Karolinska University Hospital, Huddinge, Department of Cardiology
Stockholm, Sweden
Actively Recruiting
16
Umeå University Hospital, Department of Cardiology
Umeå, Sweden
Actively Recruiting
Research Team
E
Elmir Omerovic, MD PhD
CONTACT
B
Björn Redfors, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here