NCT05711719

Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite advances in medical therapy for the prevention of coronary artery disease, such as the treatments for high blood pressure and elevated cholesterol, several hundred thousand Americans continue to experience heart attacks every year. This may be related to risk factors which are not now identified and therefore treated. Endothelial dysfunction indexes the adverse impact of multiple risk factors and thus provides the opportunity to evaluate the benefit of an intervention which may improve function. Forty-five participants with metabolic syndrome and coronary vascular dysfunction will be randomized in a 2:1 ratio to receive vericiguat or placebo. Following randomization, the participants will undergo a study drug titration phase as follows: Initial 2.5 mg/day for two weeks, then 5 mg/day for two weeks, and then 10 mg/day for two weeks. This titration protocol is the one stated in the FDA package insert for vericiguat. The vericiguat formulary will be an FDA approved version obtained by the Johns Hopkins Medical Institutions Pharmacy from Merck (manufacturer of vericiguat) and will be maintained by the Johns Hopkins Investigational Drug Service until it is administered. Cardiac MRI with isometric handgrip exercise, as well as echocardiography and blood studies will be used to assess coronary vascular and cardiac function and biomarkers indicative of nitric oxide pathways and factors impacting that pathway. The same procedures will be repeated at the end of the 6-10 week study drug administration period with an identical protocol, with special attention taken on the MRI to interrogate the same coronary segments as those studied at baseline.

Conditions

• Metabolic Syndrome
• Coronary Microvascular Dysfunction

Interventions

Type	Name	Description
DRUG	Vericiguat	Up-titration will be performed as guided by the evaluation of blood pressure and clinical symptoms
DRUG	Placebo	Administered the same way

Timeline

• Start date: 2023-06-16
• Primary completion: 2025-11-18
• Completion: 2025-11-18
• First posted: 2023-02-03
• Last updated: 2026-01-27
• Results posted: 2026-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study