Status:
UNKNOWN
Effectiveness of a Repetitive Use of 24-hour Levosimendan Infusions in Patients With Severe Systolic Heart Failure in Order to Prevent Rehospitalizations
Lead Sponsor:
Collegium Medicum w Bydgoszczy
Conditions:
Systolic Heart Failure
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
Rehospitalizations due to exacerbation of chronic heart failure are an important problem for patients suffering from heart failure. Rehospitalzations lead to worse prognosis, have an impact on the qu...
Detailed Description
Heart failure affects 12% of the adult population and its frequency increases with age and affects 10% of people over 70 years old. Heart failure is characterized by high annual death rate reaching 17...
Eligibility Criteria
Inclusion
- \- at least 2 hospitalizations due to exacerbation of chronic heart failure with reduction of left ventricular ejection fraction (EF\< 40%) during last 6 months, despite optimal heart failure treatment
Exclusion
- chronic kidney disease (GFR \< 30)
- severe liver damage (AT 5x \> N, bilirubin \>2,0 g/dl)
- hypotonia
- hypokalemia
- HGB\<10g/dl
- severe aortic and mitral stenosis
- tachycardia \>100/min or atrial fibrillation with HR \> 120/min
- features of hypovolemia
- levosimendan intolerance
- acute infection
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03764722
Start Date
August 1 2018
End Date
December 31 2021
Last Update
December 5 2018
Active Locations (1)
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1
Second Department of Cardiology
Bydgoszcz, Poland, 85-168