Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Completed · Phase 2 · Has a placebo group

Conditions studied: Metabolic Syndrome, Coronary Microvascular Dysfunction

In brief

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.

Key facts

Study ID

NCT05711719

Run by

Johns Hopkins University

People needed

45

Starts

2023-06-16

Expected to finish

2025-11-18

Last updated by the study team

2026-01-27

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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