Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 85
Healthy Volunteers: f
View:

• 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%

Locations
United States
Maryland
Johns Hopkins Hospital
RECRUITING
Baltimore
Contact Information
Primary
Thorsten M Leucker, M.D., Ph.D.
tleucke1@jhmi.edu
410-502-9453
Backup
Gary Gerstenblith, M.D.
gblith@jhmi.edu
410-955-6835
Time Frame
Start Date: 2023-06-16
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 45
Treatments
Experimental: Vericiguat
Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. Systolic blood pressure will be measured before and following each titration The participant will receive the final titration dose for a total of six weeks.. The drug is administered as an oral tablet once daily.
Placebo_comparator: Placebo
A placebo tablet will be administered orally once daily.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Johns Hopkins University

This content was sourced from clinicaltrials.gov