Phase 2
Completed N=34
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
Metabolic Syndrome · Coronary Microvascular Dysfunction
Source: ClinicalTrials.gov NCT05711719 ↗
Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcomePrimary: Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) — -1.11; 0.40 mm^2 — p=0.0005
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 vericiguat, a stimulator of soluble guanylyl cyclase, on coronary vascular function using non-invasive cardiac magnetic resonance imaging.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in Coronary Cross-sectional Area (in mm²) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) |
-1.11; 0.40 | 0.0005 sig |
| PRIMARY Relative Change in Coronary Cross-sectional Area (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) |
-6.8; 3.1 | 0.0002 sig |
| PRIMARY Absolute Change in Coronary Cross-sectional Area (in mm²) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI) |
0.40; -0.003 | 0.528 |
| PRIMARY 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) |
9.9; 8.8 | — |
| SECONDARY Changes in Interleukin 1 (IL-1) Measured Using Blood Samples (in pg/mL) |
— | — |
| SECONDARY Changes in Interleukin 6 (IL-6) Measured Using Blood Samples (in pg/mL) |
— | — |
| SECONDARY Changes in Interleukin 10 (IL-10) Measured Using Blood Samples (in pg/mL) |
— | — |
| SECONDARY Changes in Tumor Necrosis Factor (TNF)-Alpha Measured Using Blood Samples (in pg/mL) |
— | — |
| SECONDARY Changes in High Sensitivity C-Reactive Protein (hsCRP) Measured Using Blood Samples (in mg/L) |
— | — |
| SECONDARY Changes in Cyclic Guanosine Monophosphate (cGMP) Measured Using Blood Samples (in Pmol/mL) |
— | — |
| SECONDARY Changes in Left Ventricular Ejection Fraction (as Percentage) as Assessed by Echocardiography |
— | — |
| SECONDARY Changes in e' Velocities (in cm/s) as Assessed by Echocardiography |
— | — |
| SECONDARY Changes in E/e' Ratio as Assessed by Echocardiography |
— | — |
| SECONDARY Changes in Left Atrium Volume Index (in mL/BSA) as Assessed by Echocardiography |
— | — |
| SECONDARY Changes in Peak Tricuspid Regurgitation (TR) Velocity (in m/s) as Assessed by Echocardiography |
— | — |
| SECONDARY Changes in Strain (as Percentage) as Assessed by Echocardiography |
— | — |
| SECONDARY Absolute Change in Coronary Flow (in mL/Min) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Relative Change in Coronary Flow (as Percentage) Within the Vericiguat Group as Assessed by Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Absolute Change in Coronary Flow (in mL/Min) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI) |
— | — |
| SECONDARY Relative Change in Coronary Flow (as Percentage) Between the Vericiguat Group and the Placebo Group as Assessed by Magnetic Resonance Imaging (MRI) |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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 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%
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT05711719). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.