Ireland
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Recruiting Phase 4

BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.

NCT04666454 · tracked via the Priya Life Science Sweden tracker
Phase
Phase 4
Started
2020-12-14
Last updated
2024-12-02

Condition(s) studied

Takotsubo Syndrome

Investigational drug(s) / intervention(s)

Adenosine →Dipyridamole 200 mg →Apixaban 5 mg Oral Tablet →Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome

Adenosine: Adenosine infusion 70 µg/kg/min for 3 hours.

Dipyridamole 200 mg: 200 mg b.i.d

Apixaban 5 mg Oral Tablet: 5mg b.i.d

Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome: This treatment will vary depending on local routines and the degree of adherence to the recommendations.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Randomization 1: First co-primary endpoint: Wall motion score index (defined as the semi-quantitative score according to the American Society of Echocardiography) — 48-96 hours
  • Randomization 1: Second co-primary endpoint: The occurrence of the composite of death, cardiac arrest, or the need for cardiac mechanical assist device, or re-hospitalization for heart failure or ejection fraction <50% — up until day 30 day respectively at 48-96 hours
  • Randomization 2: The occurrence of any thromboembolic event (defined as ischemic stroke, peripheral arterial embolization or myocardial infarction) or death, or the presence of a cardiac thrombus, as assessed by echocardiography — up until day 30 respectively 48-96 hours

Trial sites (16)

FacilityCityRegionStatus
Aarhus Universitetshospital Aarhus Denmark Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
Oslo University Hospital Oslo Norway Recruiting
Östersund Sjukhus Östersund Jämtland Härjedalen Recruiting
Region Jönköpings Län Jönköping Region Jönköping Recruiting
Norra Älvsborgs länssjukhus Trollhättan Västra Götalands Region 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04666454 on ClinicalTrials.gov ↗ ← All trials in Sweden