Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Launched by JOHNS HOPKINS UNIVERSITY · Jan 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called vericiguat in people who have metabolic syndrome and issues with their coronary blood vessels. Metabolic syndrome is a condition that increases the risk of heart disease and is defined by several factors, including larger waist size, high blood pressure, high blood sugar, and abnormal cholesterol levels. The researchers want to see if vericiguat can improve blood flow in the heart by using a special type of imaging called cardiac magnetic resonance imaging (MRI).

To participate in this study, individuals need to be between 35 and 85 years old and have at least three signs of metabolic syndrome. They should not have significant coronary artery disease, which is a blockage in the heart's blood vessels. Participants will be given either the medication or a placebo (a dummy treatment) and will undergo MRI scans to measure how well their heart is functioning. It’s important to know that participants should not have certain medical conditions or use specific medications that could interfere with the study. Overall, this trial aims to find out if vericiguat can help improve heart health in people with metabolic syndrome.

Gender

ALL

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 \<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