Optimized treatment for Takotsubo Syndrome
BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome. A Multinational, Multicentre, Registry-based, Open-label, Randomized Controlled Trial.
This study is testing a new treatment plan for people with Takotsubo Syndrome to see if certain medications can help improve their heart function.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 16 sites (Aarhus and 15 other locations) |
| Trial ID | NCT04666454 on ClinicalTrials.gov |
What this trial studies
This study aims to document an optimized pharmacologic treatment for patients diagnosed with Takotsubo Syndrome, a condition characterized by temporary heart muscle failure. It is a randomized registry clinical trial that will include 1000 patients registered in the SWEDEHEART database. Participants will receive treatments such as Adenosine, Dipyridamole, and Apixaban, alongside care recommended by the European Society of Cardiology's Taskforce on Takotsubo Syndrome. The study seeks to establish effective treatment protocols for this under-researched condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older with a clinical diagnosis of Takotsubo Syndrome and an ejection fraction of less than 50%.
Not a fit: Patients with a life expectancy of less than one month or those with significant comorbidities such as severe valve disease or known cardiomyopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients suffering from Takotsubo Syndrome.
How similar studies have performed: While there is limited published documentation on large patient cohorts for Takotsubo Syndrome, this study represents a novel approach to optimizing treatment for this condition.
Eligibility criteria
Show full inclusion / exclusion criteria
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 exclusion criteria for Randomization 1
13. 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)
14. 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 %)
15. Ongoing treatment with dipyridamole
16. Declined participation in study 1
Specific exclusion criteria for Randomization 2
1. Any contra-indication for anticoagulant treatment.
2. Current indication for treatment with, anticoagulant or dual antiplatelet therapy
3. Declined participation in study 2
Where this trial is running
Aarhus and 15 other locations
- Aarhus Universitetshospital — Aarhus, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- Östersund Sjukhus — Östersund, Jämtland Härjedalen, Sweden (Recruiting)
- Region Jönköpings Län — Jönköping, Region Jönköping, Sweden (Recruiting)
- Norra Älvsborgs länssjukhus — Trollhättan, Västra Götalands Region, Sweden (Recruiting)
- Region Dalarna — Falun, Sweden (Recruiting)
- Sahlgrenska University Hospital, Department of Cardiology — Gothenburg, Sweden (Recruiting)
- Skaraborg Hospital — Gothenburg, Sweden (Recruiting)
- Region Skane Helsingborg Hospital — Helsingborg, Sweden (Recruiting)
- Region Oestergoetland — Linköping, Sweden (Recruiting)
- Region Skane - Skanes Universitetssjukhus — Lund, Sweden (Recruiting)
- Region Orebro lan — Örebro, Sweden (Recruiting)
- Danderyds Hospital, Department of Cardiology — Stockholm, Sweden (Recruiting)
- Karolinska University Hospital, Huddinge, Department of Cardiology — Stockholm, Sweden (Recruiting)
- Umeå University Hospital, Department of Cardiology — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Elmir Omerovic, MD PhD — Sahlgrenska University Hospital
- Study coordinator: Elmir Omerovic, MD PhD
- Email: elmir@wlab.gu.se
- Phone: 31 3421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.