The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation

• Status: Not yet recruiting
• Trial end date: 2025-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The concept that direct stimulation of soluble guanylate cyclase (sGC) could be a particularly effective approach to increase cyclic guanosine monophosphate (cGMP) in conditions of increased inflammation/oxidative stress, endothelial dysfunction, and reduced nitric oxide (NO) bioavailability. Thus, the aim of the proposed study is to examine the effect of Vericiguat on peripheral vascular function, inflammatory status, and patient health status. The study also aims to identify patients who are particularly likely to benefit from Vericiguat treatment and predict that these patients will be defined by baseline peripheral vascular dysfunction and high inflammatory state.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Josef Stehlik
• Collaborator: Merck Sharp & Dohme LLC

Criteria

Inclusion Criteria:

• History of chronic symptomatic HF (ACC/AHA Class C) and New York Heart Association (NYHA) Class II or III symptoms at the time of enrollment.

• Left ventricular ejection fraction (LVEF) of ≤45% assessed within 12 months prior to randomization by any imaging method.

• Systemic blood pressure ≥90/60 mmHg.

• Standard guideline-directed HF therapy.

• If female of reproductive potential, agrees to avoid becoming pregnant while receiving study drug and for 14 days after the last dose of study drug by complying with abstinence from heterosexual activity or use (or have her partner use) contraception during heterosexual activity.

Exclusion Criteria:

• Addition of a new disease-modifying HF pharmacotherapy or CRT-D in previous 4 weeks.

• Current or anticipated use of long-acting nitrates or nitric oxide (NO) donors including isosorbide dinitrate, isosorbide 5-mononitrate, pentaerythritol tetranitrate, nicorandil or transdermal nitroglycerin (NTG) patch, and molsidomine.

• Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.

• Current use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat.

• Known allergy or sensitivity to any sGC stimulator.

• Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2 or chronic dialysis.

• Patients who are pregnant or breastfeeding or plan to become pregnant or to breastfeed.