Rationale and Design of The SOluble guanylate Cyclase StimulatoR in HeArT FailurE Studies (SOCRATES)
Why the study?
Does vericiguat improve NT-proBNP and left atrial volume in patients with worsening chronic heart failure?
Population
Patients stabilized during hospitalization for worsening chronic heart failure at the time of discharge or…
Comparison
Vericiguat once-daily oral in four dose regimens… vs Placebo.
Design
Randomized, parallel-group, double-blind, placebo-controlled
Follow-up
12 weeks
Authors
Discussion
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Member takes
Implication
Sets stage for vericiguat assessment in worsening HF across EF spectrum; leaves open effects on NT-proBNP and atrial volume.
Structured PICO
Does vericiguat improve NT-proBNP and left atrial volume in patients with worsening chronic heart failure?
P
Population
Patients stabilized during hospitalization for worsening chronic heart failure (WCHF) at the time of discharge or within 4 weeks thereafter, including both HFrEF (LVEF <45%) and HFpEF (LVEF ≥ 45%).
I
Intervention
Vericiguat (BAY 1021189) once-daily oral in four dose regimens over 12 weeks.
C
Comparator
Placebo.
O
Outcome
Change in NT-proBNP at 12 weeks (SOCRATES-REDUCED); change in NT-proBNP and left atrial volume at 12 weeks (SOCRATES-PRESERVED).surrogate
The SOCRATES programme outlines the design of phase II trials evaluating the sGC stimulator vericiguat in patients with worsening chronic heart failure across the ejection fraction spectrum.
Cite This Study
Pieske et al. (2014) studied this question.