NCT05420012CompletedPhase 4
The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation
The Effect of Vericiguat on Peripheral Vascular Function, Patient Health Status and Inflammation in Patients With Heart Failure With Reduced Ejection Fraction
Source: ClinicalTrials.gov · Last updated 8 Oct 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 11 Jun 2022
- Start date
- 1 May 2023
- Primary completion date
- 24 Oct 2024
- Lead sponsor
- Josef Stehlik
- Diseases
- Heart failure
- NCT number
- NCT05420012
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 26
- From 1 May 2023 to the primary completion date, 24 Oct 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Addition of a new disease-modifying HF pharmacotherapy or CRT-D in previous 4 weeks.
- Current or anticipated use of phosphodiesterase type 5 (PDE5) inhibitors such as vardenafil, tadalafil, and sildenafil.
Other illness
- Known allergy or sensitivity to any sGC stimulator.
Lab values
- Estimated glomerular filtration rate (eGFR) \<15 mL/min/1.73 m2 or chronic dialysis.
Other
- 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 use or anticipated use of a soluble guanylate cyclase (sGC) stimulator such as riociguat.
- Patients who are pregnant or breastfeeding or plan to become pregnant or to breastfeed.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Utah Hospital Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Veterans Affairs Salt Lake City Health Care System (VAMC) Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.