Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: Merck Sharp & Dohme LLC

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 <40mg/dL in men or <50mg/dL in women

• Fasting blood glucose >100 mg/dL

• 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, 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 score equal to 0

• 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