This is a phase 2 randomized, double-blind, placebo-controlled study to evaluate the cardiac and renal effects of short term treatment with elamipretide in patients hospitalized with congestion due to heart failure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
308
20 mg elamipretide administered intravenously once daily for 7 consecutive days
Placebo administered intravenously once daily for 7 consecutive days
Change in NT-proBNP between Baseline and Day 8/Early Discharge
Time frame: Baseline to Day 8
Number of patients staying in the same functional renal function class measured with MDRD formula compared to the number of patients with decreasing or increasing renal function measured with MDRD formula
Time frame: Baseline to Day 3 and Day 8
Number of patients showing a decrease in body weight compared to baseline as well as number of patients showing either no decrease or an increase in body weight compared to baseline
Time frame: Baseline to Day 3 and Day 8
Calculation of decrease or increase in body weight normalised to the average dose (in mg) of furosemide administered
Time frame: Baseline to Day 3 and Day 8
The patient and physician global assessment is a 7-point scale which either the patient or the physician will assess from 0 to 10 and will be mathematically averaged on a daily basis in order to compare the different averages throughout the study.
Time frame: Baseline to Day 3 and Day 8
The average daily dose of diuretic (furosemide - adjusted for thiazide dose if administered) between baseline and Day 3 and Day 8/Early Discharge
Time frame: Baseline to Day 3 and Day 8
All adverse events, serious adverse events and SUSARs will be summarised per treatment group, namely elamipretide versus placebo, and compared at the end of the study.
Time frame: Baseline to Day 8
Half-life (T1/2)
Time frame: Baseline to Day 8
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Hospital Onze Lieve Vrouw campus Aalst
Aalst, Belgium
Hospital ZNA Middelheim
Antwerp, Belgium
Department of Internal Diseases, "Multiprofile Hospital for Active Treatment Sveta Ekaterina - Dimitrovgrad" EOOD
Dimitrovgrad, Bulgaria
Clinic of Cardiology, "Second Multiprofile Hospital for Active Treatement - Sofia" EAD
Sofia, Bulgaria
Clinic of Cardiology, Multiprofile Hospital for Active Treatment National Heart Hospital" EAD
Sofia, Bulgaria
Clinic of Cardiology, "City Clinic University Multiprofile Hospital for Active Treatment" EOOD
Sofia, Bulgaria
Clinic of Internal Diseases, "Multiprofile Hospital for Active Treatment, "Sveta Anna Sofia" AD
Sofia, Bulgaria
Department of Cardiology, "Multiprofile Regional Hospital for Active Treatement Dr. Stefan Cherkezov" AD
Veliko Tarnovo, Bulgaria
Hôpital Henri Mondor
Créteil, France
CHU de Rangueil
Toulouse, France
...and 36 more locations
Area under the concentration - time curve from 0-24 h (AUC 0-24)
Time frame: Baseline to Day 8
Area under the concentration - time curve from 0- infinity (AUC 0-∞)
Time frame: Baseline to Day 8
Peak Plasma Concentration (Cmax)
Time frame: Baseline to Day 8