Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05812755

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

Led by Vanderbilt University Medical Center · Updated on 2025-07-08

170

Participants Needed

1

Research Sites

232 weeks

Total Duration

On this page

Sponsors

V

Vanderbilt University Medical Center

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Scheduled for elective open-heart surgery involving sternotomy or thoracotomy
Not Eligible

You will not qualify if you...

  • Intolerance to vericiguat
  • Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors
  • Pregnancy or breastfeeding; pregnancy excluded by urine or serum beta hCG test in women of childbearing potential
  • Renal replacement therapy within 30 days prior to screening
  • Estimated glomerular filtration rate less than 15 ml/min per 1.73 m2 at screening
  • Systolic blood pressure less than 120 mmHg at screening
  • Prior kidney transplantation
  • History of significant liver dysfunction (Child-Pugh class C)
  • Surgery planned with circulatory arrest
  • Surgery planned to correct a major congenital heart defect
  • Extracorporeal membrane oxygenation (ECMO) prior to surgery
  • Active systemic infection or surgery for infectious endocarditis
  • Ventricular assist device or intraaortic balloon pump support prior to surgery
  • Prisoners

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37204

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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