Haemodynamic and clinical effects of ularitide in decompensated heart failure
Key result
Ularitide significantly decreased pulmonary capillary wedge pressure (P=0.000002 for 30 ng/kg/min) and improved dyspnoea scores (P=0.0013) at 6 hours in patients with decompensated heart failure.
Why the study?
Does ularitide improve haemodynamics and dyspnoea in patients with decompensated heart failure?
Population
221 patients with decompensated heart failure (DHF)
Comparison
Ularitide at 7.5 ng/kg/min, 15 ng/kg/min, or 30… vs Placebo (n=53) as a 24-h continuous infusion
Design
RCT, randomized, double-blind, placebo-controlled
Follow-up
through day 3
Authors
Discussion
Loading...
Member takes
Implication
Supports acute management of decompensated HF; extends natriuretic peptide evidence with RCT confirmation of hemodynamic and symptomatic effects.
Study Design
Type
RCT (n=221)
Blinding
Double-blind
Randomization
Randomized
Structured PICO
Does ularitide improve haemodynamics and dyspnoea in patients with decompensated heart failure?
P
Population
221 patients with decompensated heart failure treated with a 24-hour continuous infusion and followed through day 3.
I
Intervention
Ularitide at 7.5 ng/kg/min (n=60), 15 ng/kg/min (n=53), or 30 ng/kg/min (n=55) as a 24-h continuous infusion
C
Comparator
Placebo (n=53) as a 24-h continuous infusion
O
Outcome
Pulmonary capillary wedge pressure and dyspnoea score at 6 hsurrogate
Main Result
p-value: P=0.052, P=0.000004, P=0.000002 for PCWP; P=0.0026, P=0.0026, P=0.0013 for dyspnoea
In patients with decompensated heart failure, a 24-hour continuous infusion of ularitide lowers cardiac filling pressures and improves dyspnoea without early deleterious effects on renal function.
Cite This Study
Mitrovic et al. (2006) conducted an RCT in Decompensated heart failure (n=221). Ularitide vs. Placebo was evaluated on Decrease in pulmonary capillary wedge pressure and improved dyspnoea score at 6 h (p=P=0.052, P=0.000004, P=0.000002 for PCWP; P=0.0026, P=0.0026, P=0.0013 for dyspnoea). Ularitide significantly decreased pulmonary capillary wedge pressure (P=0.000002 for 30 ng/kg/min) and improved dyspnoea scores (P=0.0013) at 6 hours in patients with decompensated heart failure.