Heart FailureVERI-METNCT07901270
Metabolic Changes in Heart Failure Patients Treated With Vericiguat
An observational study of Heart Failure and Worsening Heart Failure, run by University of Salerno at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Worsening Heart Failure, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Vericiguat
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2026to 1 Nov 2028
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 18 years or older.
- Hospitalized or outpatient patients with worsening heart failure and left ventricular ejection fraction (LVEF) <45%.
- Patients receiving guideline-directed medical therapy, including an ACE inhibitor or angiotensin receptor-neprilysin inhibitor (ARNI), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.
- Patients initiating vericiguat treatment as part of optimization of heart failure therapy according to routine clinical practice.
- Provision of written informed consent before any study-specific procedures.
Who cannot join
- Age younger than 18 years.
- Pregnancy or breastfeeding.
- Previous treatment with vericiguat.
- Failure or refusal to provide written informed consent.
- Involvement in the planning or conduct of the study, including study-site personnel.
- Cardiac surgery, coronary interventions, or mitral valve interventions performed before the scheduled follow-up reassessment.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Eugenio Stabile, MD, PhD contact
Italy1 site
Azienda Ospedaliera Regionale San Carlo di Potenza
Potenza, Basilicate, 85100
About this study
Official title: Metabolic Remodelling in Worsening Heart Failure Treated With Vericiguat: A Prospective Multi-Omics Study Integrating Cardiac Imaging and Endothelial Function
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Vericiguat
- Keywords
- Vericiguat, Soluble Guanylate Cyclase, Metabolomics, Multi-Omics, Cardiac Remodeling, Endothelial Function, Echocardiography, Biomarkers, Nitric Oxide-cGMP Pathway, Personalized Medicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Vericiguat-Treated Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (2)
Change in Left Ventricular Global Longitudinal Strain
Change in left ventricular ejection fraction (LVEF), expressed as a percentage and assessed by transthoracic echocardiography.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Mazzeo, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07901270
- Sponsor's protocol ID
- V1.101122025
- Acronym
- VERI-MET
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators in patients with heart failure with reduced ejection fraction across the risk spectrum. Eur J Heart Fail. 2022 Nov;24(11):2029-2036. doi: 10.1002/ejhf.2720. Epub 2022 Nov 16.
PubMed 36250238Lam CSP, Giczewska A, Sliwa K, Edelmann F, Refsgaard J, Bocchi E, Ezekowitz JA, Hernandez AF, O'Connor CM, Roessig L, Patel MJ, Pieske B, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial. JAMA Cardiol. 2021 Jun 1;6(6):706-712. doi: 10.1001/jamacardio.2020.6455.
PubMed 33185650Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
PubMed 32222134
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Remodelling in Worsening Heart Failure Treated With Vericiguat: A Prospective Multi-Omics Study Integrating Cardiac Imaging and Endothelial Function
- ClinicalTrials.gov ID
- NCT07901270
- Acronym / sponsor ID
- VERI-MET / V1.101122025
- Keywords
- Vericiguat, Soluble Guanylate Cyclase, Metabolomics, Multi-Omics, Cardiac Remodeling, Endothelial Function, Echocardiography, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Adults aged 18 years or older.
- Hospitalized or outpatient patients with worsening heart failure and left ventricular ejection fraction (LVEF) <45%.
- Patients receiving guideline-directed medical therapy, including an ACE inhibitor or angiotensin receptor-neprilysin inhibitor (ARNI), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.
- Patients initiating vericiguat treatment as part of optimization of heart failure therapy according to routine clinical practice.
- Provision of written informed consent before any study-specific procedures.
Key exclusion criteria (7 listed)
- Age younger than 18 years.
- Pregnancy or breastfeeding.
- Previous treatment with vericiguat.
- Failure or refusal to provide written informed consent.
- Involvement in the planning or conduct of the study, including study-site personnel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatVericiguat-Treated Patients | Drug | – |
Primary outcome
Changes in Plasma Metabolomic and Lipidomic Profiles Following Vericiguat Initiation
Time frame: Baseline, 3 months, and 6 months
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.
2 secondary outcomes
Change in Left Ventricular Global Longitudinal Strain
Time frame: Baseline, 3 months, and 6 months
Change in Left Ventricular Global Longitudinal Strain
Time frame: Baseline, 3 months, and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 36250238Butler J, Usman MS, Anstrom KJ, Blaustein RO, Bonaca MP, Ezekowitz JA, Freitas C, Lam CSP, Lewis EF, Lindenfeld J, McMullan CJ, Mentz RJ, O'Connor C, Rosano GMC, Saldarriaga CI, Senni M, Udelson J, Voors AA, Zannad F. Soluble guanylate cyclase stimulators in patients with heart failure with reduced ejection fraction across the risk spectrum. Eur J Heart Fail. 2022 Nov;24(11):2029-2036. doi: 10.1002/ejhf.2720. Epub 2022 Nov 16.
- Results publication: PubMed 33185650Lam CSP, Giczewska A, Sliwa K, Edelmann F, Refsgaard J, Bocchi E, Ezekowitz JA, Hernandez AF, O'Connor CM, Roessig L, Patel MJ, Pieske B, Anstrom KJ, Armstrong PW; VICTORIA Study Group. Clinical Outcomes and Response to Vericiguat According to Index Heart Failure Event: Insights From the VICTORIA Trial. JAMA Cardiol. 2021 Jun 1;6(6):706-712. doi: 10.1001/jamacardio.2020.6455.
- Results publication: PubMed 32222134Armstrong PW, Pieske B, Anstrom KJ, Ezekowitz J, Hernandez AF, Butler J, Lam CSP, Ponikowski P, Voors AA, Jia G, McNulty SE, Patel MJ, Roessig L, Koglin J, O'Connor CM; VICTORIA Study Group. Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction. N Engl J Med. 2020 May 14;382(20):1883-1893. doi: 10.1056/NEJMoa1915928. Epub 2020 Mar 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eugenio Stabile, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Worsening Heart Failure, run by University of Salerno at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pietro Mazzeo, MD (+39 0971 616154, pmazzeo@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Plasma Metabolomic and Lipidomic Profiles Following Vericiguat Initiation (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07901270, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.