Status:
UNKNOWN
Exogenous Ketones for Acutely Decompensated HEart Failure
Lead Sponsor:
Institute for Clinical and Experimental Medicine
Conditions:
Acute Heart Failure
Low Cardiac Output Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate whether supplementation of exogenous ketones in patients with severe left ventricular dysfunction and acutely decompensated heart failure requiring inotropic therapy would imp...
Detailed Description
The study will include patients with acutely decompensated chronic heart failure requiring inotropic therapy for the syndrome of low cardiac output. While being on the inotropic therapy, the patients ...
Eligibility Criteria
Inclusion
- Chronic heart failure due ischemic or nonischemic cardiomyopathy
- Acute decompensation of heart failure with the need of inotropes
- Achievement of relative stabilization on inotropes (INTERMACS class \>2)
- Left ventricular ejection fraction \<= 35%
- Age \>18 years
Exclusion
- Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours
- Chronic kidney disease grade 4 or 5
- Diabetic ketoacidosis (3-OHB \>2mmol/l at baseline)
- Hemodynamic severe arrhythmias
- Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)
- Contraindications to invasive hemodynamic monitoring
Key Trial Info
Start Date :
December 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04698005
Start Date
December 2 2020
End Date
December 31 2021
Last Update
January 6 2021
Active Locations (1)
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1
Institute for Clinical and Experimental Medicine (IKEM)
Prague, Czechia, 14059