An observational study in Heart Failure, Worsening Heart Failure and Heart Failure With Reduced Ejection Fraction, sponsored by University of Salerno. Not yet recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by University of Salerno · Observational
Heart failure is a condition in which the heart cannot pump blood as effectively as it should. It can cause symptoms such as shortness of breath, tiredness, and fluid retention. Vericiguat is a medication used in certain patients with heart failure whose symptoms have recently worsened.
The aim of this study is to better understand how vericiguat treatment is associated with changes in metabolism, heart function, and blood vessel health in patients with heart failure.
This is a prospective, observational study conducted at a single hospital in Italy. Researchers will collect clinical information and analyze biological samples to investigate changes in molecules involved in energy production, inflammation, and cardiovascular function. Heart imaging and assessments of blood vessel function will also be used to better understand the patients' cardiovascular health.
The study will explore whether these biological and cardiovascular measurements are associated with treatment with vericiguat and whether they could help identify patients who may benefit most from this therapy.
The results may improve our understanding of heart failure and support more personalized treatment strategies in the future.
Heart failure is a complex clinical syndrome characterized by progressive cardiac dysfunction, neurohormonal activation, endothelial abnormalities, and systemic metabolic alterations. Patients experiencing worsening heart failure are at increased risk of hospitalization and adverse cardiovascular outcomes.
Vericiguat is an oral soluble guanylate cyclase (sGC) stimulator that enhances the nitric oxide-sGC-cyclic guanosine monophosphate (cGMP) signaling pathway, which is impaired in heart failure. Through this mechanism, vericiguat may influence cardiovascular and endothelial function. However, the metabolic and molecular profiles associated with vericiguat treatment in patients with worsening heart failure remain incompletely characterized.
VERI-MET is a prospective, single-center, observational study designed to investigate the metabolic and molecular characteristics associated with vericiguat treatment in patients with heart failure, integrating multi-omics analyses with clinical assessment, cardiac imaging, and endothelial function evaluation.
The study aims to characterize metabolic pathways potentially associated with vericiguat therapy, focusing on alterations in energy metabolism, mitochondrial function, lipid metabolism, and other biological processes implicated in heart failure progression.
Biological samples will be analyzed using multi-omics approaches to identify molecular signatures associated with treatment exposure and cardiovascular status. Clinical information, laboratory parameters, and cardiac imaging measurements will be collected to provide an integrated assessment of cardiac structure and function.
Endothelial function will also be investigated to explore potential relationships between metabolic profiles, vascular abnormalities, and the nitric oxide-sGC-cGMP signaling pathway.
By integrating molecular, imaging, and vascular information, the study seeks to identify potential biomarkers associated with vericiguat treatment and to improve understanding of the biological mechanisms underlying worsening heart failure.
The findings may contribute to future research on individualized therapeutic strategies and biomarker-guided management of patients with heart failure.
As an observational study, treatment decisions are made according to routine clinical practice and are not assigned by the study protocol.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University of Salerno is the lead sponsor of 21 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population consists of adult patients with worsening heart failure and left ventricular ejection fraction below 45%, hospitalized for heart failure decompensation or evaluated in an outpatient setting. Eligible patients are receiving guideline-directed medical therapy and are initiating vericiguat as part of routine clinical management. Participants will be prospectively enrolled at the Cardiology Unit of the AOR San Carlo Hospital in Potenza, Italy, and undergo clinical, biochemical, echocardiographic, and metabolomic assessments at baseline, 3 months, and 6 months.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Cardiac surgery, coronary interventions, or mitral valve interventions performed before the scheduled follow-up reassessment.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vericiguat-Treated Patients
Changes in Plasma Metabolomic and Lipidomic Profiles Following Vericiguat Initiation
Changes in the relative abundance of circulating metabolites and lipid species from baseline to 3 and 6 months after vericiguat initiation, assessed using untargeted liquid chromatography-mass spectrometry. Longitudinal changes will be analyzed to identify significantly altered molecular features and metabolic pathways associated with treatment exposure.
Time frame: Baseline, 3 months, and 6 months
Change in Left Ventricular Global Longitudinal Strain
Change in left ventricular ejection fraction (LVEF), expressed as a percentage and assessed by transthoracic echocardiography.
Time frame: Baseline, 3 months, and 6 months
Change in Left Ventricular Global Longitudinal Strain
Change in left ventricular global longitudinal strain (GLS), expressed as a percentage and measured by speckle-tracking echocardiography, to assess changes in left ventricular myocardial deformation.
Time frame: Baseline, 3 months, and 6 months
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2027, 12 months later.
Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's planned 12 months is below that.
Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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University of Salerno