Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

IRB00310207

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.

2023-06-16

2025-06-16

2025-12-31

Recruiting

Early phase I

45

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 \<40mg/dL in men or \<50mg/dL in women * 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% 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

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2024-05-07