Optimized pharmacological treatment for broken heart (takotsubo) syndrome - BROKEN-SWEDEHEART

Vastra Gotalandsregionen0 sites1,600 target enrollmentNovember 1, 2022

ConditionsTakotsubo syndrome Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Takotsubo syndrome
Sponsor: Vastra Gotalandsregionen
Enrollment: 1600
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 1, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Vastra Gotalandsregionen

Eligibility Criteria

Inclusion 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

Exclusion Criteria

•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