Vericiguat for patients with metabolic syndrome and coronary vascular dysfunction
Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction
This study is testing if a medication called vericiguat can improve heart and blood vessel function in people with metabolic syndrome and coronary vascular problems.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 35 Years to 85 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05711719 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of vericiguat, a soluble guanylyl cyclase stimulator, on coronary vascular function in individuals with metabolic syndrome and coronary vascular dysfunction. The study is a randomized, double-blind, placebo-controlled trial involving 45 participants who will receive either vericiguat or a placebo over a titration period of 6-10 weeks. Participants will undergo cardiac magnetic resonance imaging, echocardiography, and blood tests to assess changes in coronary vascular and cardiac function. The goal is to identify potential improvements in vascular function linked to nitric oxide pathways.
Who should consider this trial
Good fit: Ideal candidates are adults aged 35-85 with metabolic syndrome and evidence of coronary vascular dysfunction.
Not a fit: Patients with significant coronary artery disease or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from metabolic syndrome and related cardiovascular issues.
How similar studies have performed: While there have been studies exploring similar interventions, the specific application of vericiguat in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Thorsten M Leucker, M.D., Ph.D. — Johns Hopkins University
- Study coordinator: Thorsten M Leucker, M.D., Ph.D.
- Email: tleucke1@jhmi.edu
- Phone: 410-502-9453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.