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Cited by 366Heart Failure Treatment and ManagementCardiovascular Function and Risk FactorsHeart rate and cardiovascular health

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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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Pieske, Burkert, Maggioni, Aldo P., Lam, Carolyn S.P., Pieske-Kraigher, Elisabeth, Filippatos, Gerasimos, Butler, Javed, Ponikowski, Piotr, Shah, Sanjiv J., Solomon, Scott D., Scalise, Andrea-Viviana, Mueller, Katharina, Roessig, Lothar, Gheorghiade, Mihai·2017·European Heart Journal
DOI 10.1093/eurheartj/ehw593PMC PMC5400074
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Abstract

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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Figure 1 Patient flow and validity of analysis sets. Detailed reasons for exclusion from per protocol sets are provided in Supplementary material online, Table S1. BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; FAS, full analysis set; LAV, left atrial volume; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal pro-B-type natriuretic peptide; SAF, safety analysis set.
Figure 1 Patient flow and validity of analysis sets. Detailed reasons for exclusion from per protocol sets are provided in Supplementary material online, Table S1. BNP, B-type natriuretic peptide; eGFR, estimated glomerular filtration rate; FAS, full analysis set; LAV, left atrial volume; LVEF, left ventricular ejection fraction; NT-proBNP, N-terminal pro-B-type natriuretic peptide; SAF, safety analysis set.CC BY-NC · PubMed Central
Figure 2 Echocardiography at rest. Full analysis set excluding patients with incorrectly assigned doses. Data are displayed as mean ± standard error. (A) E wave peak velocity antegrade flow (mitral valve early diastolic filling, Doppler echo of LV diastolic inflow pattern),*1 difference relative to placebo: 9 cm/s (95% CI 2 to 17 cm/s); (B) medial e′ (mitral valve medial annular peak early diastolic tissue velocity, tissue Doppler imaging of LV relaxation),*2 baseline-adjusted linear regression slope 0.08 cm/s (95% CI 0.02 to 0.14 cm/s); (C) lateral e′ (mitral valve lateral annular peak early diastolic tissue velocity). CI, confidence interval; LV, left ventricular.
Figure 2 Echocardiography at rest. Full analysis set excluding patients with incorrectly assigned doses. Data are displayed as mean ± standard error. (A) E wave peak velocity antegrade flow (mitral valve early diastolic filling, Doppler echo of LV diastolic inflow pattern),*1 difference relative to placebo: 9 cm/s (95% CI 2 to 17 cm/s); (B) medial e′ (mitral valve medial annular peak early diastolic tissue velocity, tissue Doppler imaging of LV relaxation),*2 baseline-adjusted linear regression slope 0.08 cm/s (95% CI 0.02 to 0.14 cm/s); (C) lateral e′ (mitral valve lateral annular peak early diastolic tissue velocity). CI, confidence interval; LV, left ventricular.CC BY-NC · PubMed Central
Figure 3 Blood pressure and heart rate at given time points. Safety analysis set excluding patients with incorrectly assigned doses. Data are displayed as mean ± standard error. (A) systolic blood pressure; (B) diastolic blood pressure; (C) heart rate, difference in heart rate between the placebo and 2.5 mg vericiguat groups at 12 weeks was −3.7 bpm (95% CI −7.32 to 0.00 bpm), and between the 10 mg and placebo groups −5.9 bpm (95% CI −10.0 to −1.9 bpm). Baseline-adjusted linear regression slope −0.34 bpm (95% CI −0.66 to −0.02 bpm). bpm, beats per minute; CI, confidence interval.
Figure 3 Blood pressure and heart rate at given time points. Safety analysis set excluding patients with incorrectly assigned doses. Data are displayed as mean ± standard error. (A) systolic blood pressure; (B) diastolic blood pressure; (C) heart rate, difference in heart rate between the placebo and 2.5 mg vericiguat groups at 12 weeks was −3.7 bpm (95% CI −7.32 to 0.00 bpm), and between the 10 mg and placebo groups −5.9 bpm (95% CI −10.0 to −1.9 bpm). Baseline-adjusted linear regression slope −0.34 bpm (95% CI −0.66 to −0.02 bpm). bpm, beats per minute; CI, confidence interval.CC BY-NC · PubMed Central

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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
DOI
10.1093/eurheartj/ehw593
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
FWCI
29.10
Type
journal article
Language
en
Open access
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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