Johns Hopkins University
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.
Metabolic Syndrome
Coronary Microvascular Dysfunction
vericiguat
Placebo
Phase 2
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.}}
Study Type : | Interventional |
Estimated Enrollment : | 45 participants |
Masking : | Quadruple |
Primary Purpose : | Prevention |
Official Title : | Vericiguat in Patients With Metabolic Syndrome and Coronary Vascular Dysfunction |
Actual Study Start Date : | June 16, 2023 |
Estimated Primary Completion Date : | June 16, 2025 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
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. |
Drug: Vericiguat |
Placebo Comparator: Placebo A placebo tablet will be administered orally once daily. |
Drug: Placebo |
Ages Eligible for Study: | 35 Years to 85 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287