Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Pieske, B; Butler, J; Filippatos, G; Lam, C; Maggioni, AP; Ponikowski, P; Shah, S; Solomon, S; Kraigher-Krainer, E; Samano, ET; Scalise, AV; Müller, K; Roessig, L; Gheorghiade, M; SOCRATES Investigators and Coordinators.
Rationale and design of the SOluble guanylate Cyclase stimulatoR in heArT failurE Studies (SOCRATES).
Eur J Heart Fail. 2014; 16(9):1026-1038
Doi: 10.1002/ejhf.135
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- Co-Autor*innen der Med Uni Graz
- Kraigher-Krainer Elisabeth
- Pieske Burkert Mathias
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- Abstract:
- The clinical outcomes for patients with worsening chronic heart failure (WCHF) remain exceedingly poor despite contemporary evidence-based therapies, and effective therapies are urgently needed. Accumulating evidence supports augmentation of cyclic guanosine monophosphate (cGMP) signalling as a potential therapeutic strategy for HF with reduced or preserved ejection fraction (HFrEF and HFpEF, respectively). Direct soluble guanylate cyclase (sGC) stimulators target reduced cGMP generation due to insufficient sGC stimulation and represent a promising method for cGMP enhancement. The phase II SOluble guanylate Cyclase stimulatoR in heArT failurE Study (SOCRATES) programme consists of two randomized, parallel-group, placebo-controlled, double-blind, multicentre studies, SOCRATES-REDUCED (in patients with LVEF <45%) and SOCRATES-PRESERVED (in those with LVEF ≥ 45%), that will explore the pharmacodynamic effects, safety and tolerability, and pharmacokinetics of four dose regimens of the once-daily oral sGC stimulator vericiguat (BAY 1021189) over 12 weeks compared with placebo. These studies will enrol patients stabilized during hospitalization for HF at the time of discharge or within 4 weeks thereafter. The primary endpoint in SOCRATES-REDUCED is change in NT-proBNP at 12 weeks. The primary endpoints in SOCRATES-PRESERVED are change in NT-proBNP and left atrial volume at 12 weeks. SOCRATES will be the first programme to enrol specifically both inpatients and outpatients with WCHF and patients with reduced or preserved ejection fraction. Results will inform the benefits of pursuing subsequent event-driven clinical outcome trials with sGC stimulators in this patient population. © 2014 The Authors. European Journal of Heart Failure © 2014 European Society of Cardiology.
- Find related publications in this database (using NLM MeSH Indexing)
- Administration, Oral -
- Aged -
- Double-Blind Method -
- Female -
- Guanylate Cyclase - administration & dosage Guanylate Cyclase - pharmacokinetics
- Heart Failure - blood Heart Failure - drug therapy Heart Failure - physiopathology
- Humans -
- Male -
- Natriuretic Peptide, Brain - blood
- Peptide Fragments - blood
- Prognosis -
- Protein Precursors -
- Receptors, Cytoplasmic and Nuclear - administration & dosage Receptors, Cytoplasmic and Nuclear - pharmacokinetics
- Stroke Volume - physiology
- Treatment Outcome -
- Find related publications in this database (Keywords)
- Worsening chronic heart failure
- Reduced ejection fraction
- Preserved ejection fraction
- Soluble guanylate cyclase
- Natriuretic peptides
- Left atrial volume