COMPLETED

Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

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Conditions

Metabolic SyndromeCoronary Microvascular DysfunctionCardiac Magnetic Resonance Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

Quick Facts

Study Start:2023-06-16
Study Completion:2025-11-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05711719

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age range 35-85 years
  2. * 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:
  3. * waist circumference \> 40 inches (men) or \>35 inches (women)
  4. * blood pressure \>130/80 mmHg
  5. * fasting triglyceride (TG) level \>150 mg/dL
  6. * fasting high-density lipoprotein (HDL) cholesterol level \<40mg/dL in men or \<50mg/dL in women
  7. * Fasting blood glucose \>100 mg/dL, or hemoglobin A1c greater or equal to 5.7%
  8. * Either one of the following:
  9. * Men ≤ 40 or women ≤ 50 years of age with no history or symptoms of ischemic heart disease, or
  10. * Men \>40 or women \>50 years of age with either one of the following
  11. * 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
  12. * 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.
  13. * IHE-induced %-change in coronary flow ≤13%
  1. * Systolic blood pressure \<110 mm Hg
  2. * Current or anticipated use of long-acting nitrates, soluble guanylate cyclase (sGC) stimulators, or phosphodiesterase type 5 (PDE5) inhibitors
  3. * Hematocrit \<30%
  4. * Unable to understand the risks, benefits, and alternatives of participation so as to provide informed consent
  5. * Women who are pregnant.
  6. * Women with reproductive capacity not using an acceptable form of contraception
  7. * History of claustrophobia
  8. * Inability to lie flat and still for 45 minutes
  9. * 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
  10. * History as a machinist, welder, metal worker or a similar activity that poses the risk of metal exposure to the eyes

Contacts and Locations

Principal Investigator

Thorsten M Leucker, M.D., Ph.D.
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Thorsten M Leucker, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-16
Study Completion Date2025-11-18

Study Record Updates

Study Start Date2023-06-16
Study Completion Date2025-11-18

Terms related to this study

Keywords Provided by Researchers

  • Cardiac Magnetic Resonance Imaging

Additional Relevant MeSH Terms

  • Metabolic Syndrome
  • Coronary Microvascular Dysfunction