SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery

NCT05812755 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2025-07-08

No results posted yet for this study

Summary

The goal of this mechanistic clinical trial is to learn about the effects of medications called soluble guanylyl cyclase stimulators on vascular function and markers of kidney and brain injury in patients having heart surgery. The main questions it aims to answer are:

1. Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo?
2. Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo?

Participants will be randomized to a soluble guanylyl cyclase stimulator called vericiguat or placebo, and researchers will compare vascular function and markers of brain and kidney injury to see if vericiguat improves vascular function and reduces markers of injury.

This will provide important information to determine the underlying reasons that patients have some kidney and brain function problems after having heart surgery.

Conditions

  • Endothelial Dysfunction
  • Vascular Diseases
  • Kidney Injury
  • Brain Disease
  • Vascular Inflammation

Interventions

DRUG

Vericiguat

Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery

DRUG

Placebo

Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Marcos Lopez, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-19
Primary Completion
2026-12-31
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT05812755 on ClinicalTrials.gov