Evidence map›Paper›PMID 28369340›Full record

Trial reportEuropean heart journal2017

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.

Burkert Pieske, Aldo P Maggioni, Carolyn S P Lam, Elisabeth Pieske-Kraigher, Gerasimos Filippatos, Javed Butler, Piotr Ponikowski, Sanjiv J Shah, Scott D Solomon, Andrea-Viviana Scalise and 3 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 180 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
180citing papers in PubMed, 14 pooled it
23.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

180 citing papers in PubMed, 14 syntheses or guidelines pooled it, 351 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Efficacy and safety of vericiguat in heart failure: a meta-analysis.The Journal of international medical research · 2023
    Pooled it
  10. Pooled it
  11. Highlights in heart failure.ESC heart failure · 2019
    Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. Trial

120 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 6 countries.

Burkert PieskeCharité Universitätsmedizin, Department of Internal Medicine and Cardiology, Charité University Medicine, Augustenburgerplatz 1, 13353 Berlin, Germany, and Department of Internal Medicine Cardiology, German Heart Center Berlin, DZHK (German Center for Cardiovascular Research) and Berlin Institute of Health (BIH).
Aldo P MaggioniAssociazione Nazionale Medici Cardiologi Ospedalieri Research Center, Via La Marmora 36, 50121 Firenze, Italy.
Carolyn S P LamNational Heart Centre Singapore and Duke-NUS Graduate Medical School, 5, Hospital Drive, Singapore 169609, Singapore.
Elisabeth Pieske-KraigherDepartment of Internal Medicine and Cardiology, Charité University Medicine, Augustenburgerplatz 1, 13353 Berlin, Germany.
Gerasimos FilippatosNational and Kapodistrian University of Athens, School of Medicine, Attikon University Hospital, Rimini 1, 12462, Athens, Greece.
Javed ButlerDivision of Cardiology, Stony Brook University, 101 Nicolls Road, Stony Brook, NY 11794, USA.
Piotr PonikowskiWroclaw Medical University, 4th Military Hospital, Weigla 5, Wroclaw 50-981, Poland.
Sanjiv J ShahNorthwestern University, 676 N. St. Clair St., Suite 600, Chicago, IL 60611, USA.
Scott D SolomonBrigham and Women's Hospital, Cardiovascular Division, 75 Francis Street, Boston, MA 02115, USA.
Andrea-Viviana ScaliseBayer AG, Aprather Weg 18, 42113 Wuppertal, Germany.
Katharina MuellerBayer AG, Aprather Weg 18, 42113 Wuppertal, Germany.
Lothar RoessigBayer AG, Aprather Weg 18, 42113 Wuppertal, Germany.
Mihai GheorghiadeNorthwestern University Feinberg School of Medicine, 201 East Huron Street Galter 3-150, Chicago, IL 60601, USA.
Bayer (Germany) · DENorthwestern University · USAssociazione Nazionale Medici Cardiologi Ospedalieri · ITBrigham and Women's Hospital · USCharité - Universitätsmedizin Berlin · DEDuke-NUS Medical School · SGGerman Centre for Cardiovascular Research · DENational and Kapodistrian University of Athens · GRStony Brook University · USWroclaw Medical University · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

AgedAtrial Function, LeftCardiotonic AgentsChronic DiseaseDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHeart FailureHeterocyclic Compounds, 2-RingHumansMaleNatriuretic Peptide, BrainPeptide FragmentsProspective StudiesPyrimidinesCardiotonic AgentsHeterocyclic Compounds, 2-RingNatriuretic Peptide, BrainPeptide Fragmentspro-brain natriuretic peptide (1-76)PyrimidinesSoluble Guanylyl CyclasevericiguatHeart failure with preserved ejection fractionSoluble guanylate cyclase stimulatorVericiguat

Identifiers

PMID28369340
PMCPMC5400074
OpenAlexW2603535098

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.