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

NCT05420012 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-10-08

Study results available
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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.

Conditions

  • Heart Failure
  • Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

DRUG

Vericiguat

A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.

DRUG

Placebo

A starting dose of vericiguat 2.5 mg or matching placebo will be initiated after randomization and completion of the baseline testing. Subjects will be up-titrated in a blinded fashion to 5 mg and then to the target dose of 10 mg of vericiguat or matching placebo using titration criteria based on mean systolic blood pressure(SBP) evaluation and clinical symptoms at 2 week intervals. Titration to 10 mg in subjects who have not yet reached the target dose is intended at every visit/phone call throughout the study duration based on mean SBP measurement and safety considerations, at the discretion of the investigator.

Sponsors & Collaborators

Principal Investigators

  • Josef Stehlik, M.D, M.P.H. · University of Utah Health Science Center & Veterans Affairs Salt Lake City Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-10-24
Completion
2024-10-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05420012 on ClinicalTrials.gov