Metabolic SyndromePhase 2NCT05711719
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
A Phase 2 study testing Vericiguat in people with Metabolic Syndrome and Coronary Microvascular Dysfunction, run by Johns Hopkins University at 1 site in United States.
Trial summary
Coronary vascular dysfunction is one of the "final common pathways" for the impact of multiple cardiovascular risk factors. The investigators will conduct a randomized, double-blind placebo-controlled study in individuals with the metabolic syndrome and baseline coronary vascular dysfunction to evaluate the impact of… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Metabolic Syndrome, Coronary Microvascular Dysfunction
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to 18 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 35-85 years
- Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria:
- waist circumference > 40 inches (men) or >35 inches (women)
- blood pressure >130/80 mmHg
- fasting triglyceride (TG) level >150 mg/dL
- fasting high-density lipoprotein (HDL) cholesterol level <40mg/dL in men or <50mg/dL in women
Show all 13Show fewer
- Fasting blood glucose >100 mg/dL, or hemoglobin A1c greater or equal to 5.7%
- Either one of the following:
- Men ≤ 40 or women ≤ 50 years of age with no history or symptoms of ischemic heart disease, or
- Men >40 or women >50 years of age with either one of the following
- a coronary angiography within the past 24 months showing no significant coronary artery disease in a t least one major vessel, defined as >50% stenosis of the left main coronary artery and/or >70% stenosis of another major coronary vessel, or
- a coronary artery calcium score obtained within the prior 24 months or if no prior calcium scan, one performed as a research study following consent with a Agatston score <10 in at least one major coronary vessel.
- IHE-induced %-change in coronary flow ≤13%
Who cannot join
- Systolic blood pressure <110 mm Hg
- Current or anticipated use of long-acting nitrates, soluble guanylate cyclase (sGC) stimulators, or phosphodiesterase type 5 (PDE5) inhibitors
- Hematocrit <30%
- Unable to understand the risks, benefits, and alternatives of participation so as to provide informed consent
- Women who are pregnant.
- Women with reproductive capacity not using an acceptable form of contraception
Show all 10Show fewer
- History of claustrophobia
- Inability to lie flat and still for 45 minutes
- Presence of non-magnetic resonance (MR)-compatible objects or devices, such as intra-orbital debris, intra-auricular implants, intra-cranial clips, an implanted defibrillator or a pacemaker
- History as a machinist, welder, metal worker or a similar activity that poses the risk of metal exposure to the eyes
Trial locations and contacts
1 site in 1 country.
About this study
Coronary vascular dysfunction is one of the "final common pathways" for the impact of multiple cardiovascular risk factors. The investigators will conduct a randomized, double-blind placebo-controlled study in individuals with the metabolic syndrome and baseline coronary vascular dysfunction to evaluate the impact of vericiguat, a stimulator of soluble guanylyl cyclase, on coronary vascular function using non-invasive cardiac magnetic resonance imaging.
Read the detailed description
Despite advances in medical therapy for the prevention of coronary artery disease, such as the treatments for high blood pressure and elevated cholesterol, several hundred thousand Americans continue to experience heart attacks every year. This may be related to risk factors which are not now identified and therefore treated. Endothelial dysfunction indexes the adverse impact of multiple risk factors and thus provides the opportunity to evaluate the benefit of an intervention which may improve function.
Forty-five participants with metabolic syndrome and coronary vascular dysfunction will be randomized in a 2:1 ratio to receive vericiguat or placebo. Following randomization, the participants will undergo a study drug titration phase as follows: Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. This titration protocol is the one stated in the FDA package insert for vericiguat. The vericiguat formulary will be an FDA approved version obtained by the Johns Hopkins Medical Institutions Pharmacy from Merck (manufacturer of vericiguat) and will be maintained by the Johns Hopkins Investigational Drug Service until it is administered.
Cardiac MRI with isometric handgrip exercise, as well as echocardiography and blood studies will be used to assess coronary vascular and cardiac function and biomarkers indicative of nitric oxide pathways and factors impacting that pathway. The same procedures will be repeated at the end of the 6-10 week study drug administration period with an identical protocol, with special attention taken on the MRI to interrogate the same coronary segments as those studied at baseline.
- Being tested
- Vericiguat, Placebo
- Keywords
- Cardiac Magnetic Resonance Imaging
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Also called Verquvo
Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
PlaceboDrug
Administered the same way
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat | Experimental | Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily. Receives: Drug: Vericiguat |
| Placebo | Placebo comparator | A placebo tablet will be administered orally once daily. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Relative Change in Coronary Cross-sectional Area (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
The difference in relative change in coronary cross-sectional area (in %) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Absolute Change in Coronary Cross-sectional Area (in mm²) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Difference in Percent Change in Coronary Cross-sectional Area (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
The difference in percentage change in coronary cross-sectional area (%) from rest to isometric handgrip exercise (IHE) between the vericiguat and placebo groups, as assessed from the baseline MRI to the follow-up MRI, six weeks following initiation of the titrated dose.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Secondary outcomes (16)
Changes in Interleukin 1 (IL-1) Measured Using Blood Samples (in pg/mL)
IL-1 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Interleukin 6 (IL-6) Measured Using Blood Samples (in pg/mL)
IL-6 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Interleukin 10 (IL-10) Measured Using Blood Samples (in pg/mL)
IL-10 (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Tumor Necrosis Factor (TNF)-Alpha Measured Using Blood Samples (in pg/mL)
TNF-alpha (in pg/mL), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in High Sensitivity C-Reactive Protein (hsCRP) Measured Using Blood Samples (in mg/L)
hsCRP (in mg/L), an inflammatory marker, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Cyclic Guanosine Monophosphate (cGMP) Measured Using Blood Samples (in Pmol/mL)
cGMP (in pmol/mL), a mediator in the nitric oxide pathway, will be measured in blood samples to assess changes from baseline.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Left Ventricular Ejection Fraction (as Percentage) as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on left ventricular ejection fraction (%).
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in e' Velocities (in cm/s) as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on e' velocities (in cm/s).
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in E/e' Ratio as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the E/e' ratio.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Left Atrium Volume Index (in mL/BSA) as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on the left atrium volume index (in mL/BSA).
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Peak Tricuspid Regurgitation (TR) Velocity (in m/s) as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on peak TR velocity (in m/s).
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Strain (as Percentage) as Assessed by Echocardiography
An ultrasound evaluation of the heart will be performed to assess the impact of vericiguat on strain (as percentage).
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Absolute Change in Coronary Flow (in mL/Min) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Relative Change in Coronary Flow (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
The relative changes in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Absolute Change in Coronary Flow (in mL/Min) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
The absolute changes in coronary flow (in mL/min) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Relative Change in Coronary Flow (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
The relative changes in in coronary flow (as percentage) with isometric handgrip exercise (IHE) in the vericiguat group as compared to the placebo group as assessed by MRI.
Measured: Baseline and 6 weeks following initiation of up-titrated dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start16 Jun 2023
- Primary completion18 Nov 2025
- Study completion18 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Thorsten M Leucker, M.D., Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711719
- Sponsor's protocol ID
- IRB00310207
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2022
- Last updated
- 27 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
PubMed 35078371Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
PubMed 14744958Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.
PubMed 15198963Hays AG, Iantorno M, Soleimanifard S, Steinberg A, Schar M, Gerstenblith G, Stuber M, Weiss RG. Coronary vasomotor responses to isometric handgrip exercise are primarily mediated by nitric oxide: a noninvasive MRI test of coronary endothelial function. Am J Physiol Heart Circ Physiol. 2015 Jun 1;308(11):H1343-50. doi: 10.1152/ajpheart.00023.2015. Epub 2015 Mar 27.
PubMed 25820391Hays AG, Hirsch GA, Kelle S, Gerstenblith G, Weiss RG, Stuber M. Noninvasive visualization of coronary artery endothelial function in healthy subjects and in patients with coronary artery disease. J Am Coll Cardiol. 2010 Nov 9;56(20):1657-65. doi: 10.1016/j.jacc.2010.06.036.
PubMed 21050976Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11.
PubMed 29032136Jones SP, Bolli R. The ubiquitous role of nitric oxide in cardioprotection. J Mol Cell Cardiol. 2006 Jan;40(1):16-23. doi: 10.1016/j.yjmcc.2005.09.011. Epub 2005 Nov 8.
PubMed 16288777Tsai EJ, Kass DA. Cyclic GMP signaling in cardiovascular pathophysiology and therapeutics. Pharmacol Ther. 2009 Jun;122(3):216-38. doi: 10.1016/j.pharmthera.2009.02.009. Epub 2009 Mar 21.
PubMed 19306895Stasch JP, Pacher P, Evgenov OV. Soluble guanylate cyclase as an emerging therapeutic target in cardiopulmonary disease. Circulation. 2011 May 24;123(20):2263-73. doi: 10.1161/CIRCULATIONAHA.110.981738. No abstract available.
PubMed 21606405
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
- ClinicalTrials.gov ID
- NCT05711719
- Acronym / sponsor ID
- IRB00310207
- Keywords
- Cardiac Magnetic Resonance Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 18 Nov 2025 (actual)
- First posted
- 3 Feb 2023 (actual)
- Results
- Posted 27 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Coronary vascular dysfunction is one of the "final common pathways" for the impact of multiple cardiovascular risk factors. The investigators will conduct a randomized, double-blind placebo-controlled study in individuals with the metabolic syndrome and baseline coronary vascular dysfunction to evaluate the impact of vericiguat, a stimulator of soluble guanylyl cyclase, on coronary vascular function using non-invasive cardiac magnetic resonance imaging.
Detailed description
Despite advances in medical therapy for the prevention of coronary artery disease, such as the treatments for high blood pressure and elevated cholesterol, several hundred thousand Americans continue to experience heart attacks every year. This may be related to risk factors which are not now identified and therefore treated. Endothelial dysfunction indexes the adverse impact of multiple risk factors and thus provides the opportunity to evaluate the benefit of an intervention which may improve function.
Forty-five participants with metabolic syndrome and coronary vascular dysfunction will be randomized in a 2:1 ratio to receive vericiguat or placebo. Following randomization, the participants will undergo a study drug titration phase as follows: Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. This titration protocol is the one stated in the FDA package insert for vericiguat. The vericiguat formulary will be an FDA approved version obtained by the Johns Hopkins Medical Institutions Pharmacy from Merck (manufacturer of vericiguat) and will be maintained by the Johns Hopkins Investigational Drug Service until it is administered.
Cardiac MRI with isometric handgrip exercise, as well as echocardiography and blood studies will be used to assess coronary vascular and cardiac function and biomarkers indicative of nitric oxide pathways and factors impacting that pathway. The same procedures will be repeated at the end of the 6-10 week study drug administration period with an identical protocol, with special attention taken on the MRI to interrogate the same coronary segments as those studied at baseline.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| Vericiguat | Experimental | Drug: VericiguatInitial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily. |
| Placebo | Placebo comparator | Drug: PlaceboA placebo tablet will be administered orally once daily. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age range 35-85 years
- Presence of the metabolic syndrome defined by the National Cholesterol Education Program, Adult Treatment Panel III (NCEP ATP III) definition, with at least three of the following five criteria:
- Either one of the following:
- IHE-induced %-change in coronary flow ≤13%
Key exclusion criteria (10 listed)
- Systolic blood pressure <110 mm Hg
- Current or anticipated use of long-acting nitrates, soluble guanylate cyclase (sGC) stimulators, or phosphodiesterase type 5 (PDE5) inhibitors
- Hematocrit <30%
- Unable to understand the risks, benefits, and alternatives of participation so as to provide informed consent
- Women who are pregnant.
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 |
|---|---|---|
| VericiguatAlso: VerquvoUp-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms | Drug | Vericiguat |
| PlaceboAdministered the same way | Drug | Placebo |
Primary outcome
Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline, prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Relative Change in Coronary Cross-sectional Area (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
The difference in relative change in coronary cross-sectional area (in %) from rest to isometric handgrip exercise (IHE) in the group randomized to vericiguat from that measured at baseline prior to the initiation of vericiguat, to that measured at the end of the study drug administration period, six weeks following initiation of the titrated dose, as assessed by MRI.
Absolute Change in Coronary Cross-sectional Area (in mm²) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
The difference in absolute change in coronary cross-sectional area (in mm²) from rest to isometric handgrip exercise (IHE) as assessed by MRI.
Difference in Percent Change in Coronary Cross-sectional Area (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
The difference in percentage change in coronary cross-sectional area (%) from rest to isometric handgrip exercise (IHE) between the vericiguat and placebo groups, as assessed from the baseline MRI to the follow-up MRI, six weeks following initiation of the titrated dose.
16 secondary outcomes
Changes in Interleukin 1 (IL-1) Measured Using Blood Samples (in pg/mL)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Interleukin 6 (IL-6) Measured Using Blood Samples (in pg/mL)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Interleukin 10 (IL-10) Measured Using Blood Samples (in pg/mL)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Tumor Necrosis Factor (TNF)-Alpha Measured Using Blood Samples (in pg/mL)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in High Sensitivity C-Reactive Protein (hsCRP) Measured Using Blood Samples (in mg/L)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Cyclic Guanosine Monophosphate (cGMP) Measured Using Blood Samples (in Pmol/mL)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Left Ventricular Ejection Fraction (as Percentage) as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in e' Velocities (in cm/s) as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in E/e' Ratio as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Left Atrium Volume Index (in mL/BSA) as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Peak Tricuspid Regurgitation (TR) Velocity (in m/s) as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Changes in Strain (as Percentage) as Assessed by Echocardiography
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Absolute Change in Coronary Flow (in mL/Min) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Relative Change in Coronary Flow (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Absolute Change in Coronary Flow (in mL/Min) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Relative Change in Coronary Flow (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI)
Time frame: Baseline and 6 weeks following initiation of up-titrated dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 35078371Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26.
- Background: PubMed 14744958Grundy SM, Brewer HB Jr, Cleeman JI, Smith SC Jr, Lenfant C; American Heart Association; National Heart, Lung, and Blood Institute. Definition of metabolic syndrome: Report of the National Heart, Lung, and Blood Institute/American Heart Association conference on scientific issues related to definition. Circulation. 2004 Jan 27;109(3):433-8. doi: 10.1161/01.CIR.0000111245.75752.C6. No abstract available.
- Background: PubMed 15198963Davignon J, Ganz P. Role of endothelial dysfunction in atherosclerosis. Circulation. 2004 Jun 15;109(23 Suppl 1):III27-32. doi: 10.1161/01.CIR.0000131515.03336.f8.
- Background: PubMed 25820391Hays AG, Iantorno M, Soleimanifard S, Steinberg A, Schar M, Gerstenblith G, Stuber M, Weiss RG. Coronary vasomotor responses to isometric handgrip exercise are primarily mediated by nitric oxide: a noninvasive MRI test of coronary endothelial function. Am J Physiol Heart Circ Physiol. 2015 Jun 1;308(11):H1343-50. doi: 10.1152/ajpheart.00023.2015. Epub 2015 Mar 27.
- Background: PubMed 21050976Hays AG, Hirsch GA, Kelle S, Gerstenblith G, Weiss RG, Stuber M. Noninvasive visualization of coronary artery endothelial function in healthy subjects and in patients with coronary artery disease. J Am Coll Cardiol. 2010 Nov 9;56(20):1657-65. doi: 10.1016/j.jacc.2010.06.036.
- Background: PubMed 29032136Armstrong PW, Roessig L, Patel MJ, Anstrom KJ, Butler J, Voors AA, Lam CSP, Ponikowski P, Temple T, Pieske B, Ezekowitz J, Hernandez AF, Koglin J, O'Connor CM. A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator: The VICTORIA Trial. JACC Heart Fail. 2018 Feb;6(2):96-104. doi: 10.1016/j.jchf.2017.08.013. Epub 2017 Oct 11.
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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. This study is not recruiting at the moment.
Thorsten M Leucker, M.D., Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vericiguat in people with Metabolic Syndrome and Coronary Microvascular Dysfunction, run by Johns Hopkins University at 1 site in United States.
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 13 inclusion and 10 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: finished, as of the sponsor's last update on 27 Jan 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) (time frame: Baseline and 6 weeks following initiation of up-titrated dose). The study lists 4 primary outcomes in all. 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 NCT05711719, which also lists 9 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 27 Jan 2026.