Vericiguat in patients with worsening chronic heart failure and preserved ejection fraction: results of the SOluble guanylate Cyclase stimulatoR in heArT failurE patientS with PRESERVED EF (SOCRATES-PRESERVED) study
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Aims: To determine tolerability and the optimal dose regimen of the soluble guanylate cyclase stimulator vericiguat in patients with chronic heart failure and preserved ejection fraction (HFpEF). Methods and results: SOCRATES-PRESERVED was a prospective, randomized, placebo-controlled double-blind, Phase 2b dose-finding study in patients with HFpEF (ejection fraction ≥ 45%). Patients received vericiguat once daily at 1.25 or 2.5 mg fixed doses, or 5 or 10 mg titrated from a 2.5 mg starting dose, or placebo for 12 weeks. The two primary endpoints were change from baseline in log-transformed N-terminal pro-B-type natriuretic peptide (NT-ProBNP) and left atrial volume (LAV) at 12 weeks. Patients (N = 477; 48% women; mean age 73 ± 10 years; baseline atrial fibrillation 40%) were randomized within 4 weeks of HF hospitalization (75%) or outpatient treatment with intravenous diuretics for HF (25%) to vericiguat (n = 384) or placebo (n = 93). In the pooled three highest dose arms change in logNT-proBNP (vericiguat: +0.038 ± 0.782 log(pg/mL), n = 195; placebo: -0.098 ± 0.778 log(pg/mL), n = 73; one-sided P = 0.8991, two-sided P = 0.2017), and change in LAV [vericiguat: -1.7 ± 12.8 mL (n = 194); placebo: -3.4 ± 12.7 mL (n = 67), one-sided P = 0.8156, two-sided P = 0.3688] were not different from placebo. Vericiguat was well tolerated (adverse events: vericiguat 10 mg arm, 69.8%; placebo, 73.1%), with low discontinuation rates in all groups, and no changes in blood pressure at 10 mg compared with placebo. The pre-specified exploratory endpoint of Kansas City Cardiomyopathy Questionnaire Clinical Summary Score improved in the vericiguat 10 mg arm by mean 19.3 ± 16.3 points [median 19.8 (interquartile range 10.4-30.7)] from baseline (mean difference from placebo 9.2 points). Conclusion: Vericiguat was well tolerated, did not change NT-proBNP and LAV at 12 weeks compared with placebo but was associated with improvements in quality of life in patients with HFpEF. Given the encouraging results on quality of life, the effects of vericiguat in patients with HFpEF warrant further study, possibly with higher doses, longer follow-up and additional endpoints.
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Acute supplementation of BH4, either orally or injected, generally improves vasodilatation.
“Acute supplementation of BH4, either orally or injected, generally improves vasodilatation.”
From Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation (2019) · cites this paper as [743]
Acute BH4 improves vasodilatation in healthy individuals and patients with hypertension, hypercholesterolemia, chronic heart failure, coronary artery disease, heart failure with reduced ejection fraction, rheumatoid arthritis, or smokers.
“This effect has been observed in a number of human studies, including healthy individuals (450, 743, 987) and patients with hypertension (429), hypercholesterolemia (318, 899, 1031), chronic heart failure (849), coronary artery disease (618, 850), heart failure with reduced ejection fraction (178), or rheumatoid arthritis (619) or smokers (418, 929, 957).”
From Sources of Vascular Nitric Oxide and Reactive Oxygen Species and Their Regulation (2019) · cites this paper as [743]
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- Authors
- Pieske, B., Maggioni, A. P., Lam, C. S. P., Pieske-Kraigher, E., Filippatos, G., Butler, J., Ponikowski, P., Shah, S. J., Solomon, S. D., Scalise, A.-V., Mueller, K., Roessig, L., & Gheorghiade, M.
- Affiliations
- Deutsches Herzzentrum der Charité (DE)
- Associazione Nazionale Medici Cardiologi Ospedalieri (IT)
- National University of Singapore (SG)
- Department of Internal Medicine and Cardiology, Charité University Medicine, Augustenburgerplatz 1, 13353 Berlin, Germany
- National and Kapodistrian University of Athens (GR)
- Stony Brook University (US)
- Wroclaw Medical University (PL)
- Northwestern University (US)
- Brigham and Women's Hospital (US)
- Bayer (Germany) (DE)
- Corresponding author
- Pieske, Burkert
- ORCID
- Venue
- European Heart Journal
- Publisher
- Oxford University Press (OUP)
- Published
- 2017-03-22
- Volume
- 38
- Issue
- 15
- Pages
- 1119-1127
- ISSN
- 0195-668X (ISSN-L)
- 1522-9645
- PMC
- PMC5400074
- OpenAlex
- W2603535098
- Cited by
- 366
- References
- 23
- Citations by year
- 2026: 22 · 2025: 22 · 2024: 28 · 2023: 45 · 2022: 46 · 2021: 49 · 2020: 46 · 2019: 39 · 2018: 49 · 2017: 17 · 2016: 1
- FWCI
- 29.10
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc
- Locations
- European Heart Journal (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- Funders
- AstraZeneca
- Bayer
- Boston Scientific Corporation
- Bayer HealthCare
- Daiichi-Sankyo
- Vifor Pharma
- Servier
- Abbott Vascular
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart Failure Treatment and Management
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Function and Risk Factors
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart rate and cardiovascular health
- Keywords
- vericiguat, soluble guanylate cyclase stimulator, heart failure with preserved ejection fraction, NT-proBNP, left atrial volume, drug tolerability, dose titration, atrial fibrillation, blood pressure, diuretic therapy, heart failure hospitalization, natriuretic peptides, left ventricular ejection fraction
- MeSH terms
- Soluble Guanylyl Cyclase, Aged, Cardiotonic Agents, Chronic Disease, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Heart Failure, Heterocyclic Compounds, 2-Ring, Humans, Male, Peptide Fragments, Prospective Studies, Pyrimidines, Stroke Volume, Atrial Function, Left, Treatment Outcome, Natriuretic Peptide, Brain
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