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The Effects of Soluble Guanylyl Cyclase Stimulation on 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
47 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
Researchers are evaluating the effects of medications called soluble guanylyl cyclase stimulators on blood vessel function and markers of kidney and brain injury in patients undergoing heart surgery. The study aims to find out if stimulating soluble guanylyl cyclase with a drug called vericiguat improves blood vessel function and reduces injury markers compared to a placebo. This research will help understand why some patients experience kidney and brain problems after heart surgery. Participants will be randomly assigned to receive either vericiguat, an oral medication given once daily at 10 mg for three days starting two days before surgery through the day of surgery, or a matching placebo under the same schedule. Vascular function will be measured using ultrasound and direct tests of artery relaxation outside the body. Blood and urine samples will be collected to measure markers of brain and kidney injury. During the study, participants will have assessments on the day of surgery and through two days after surgery. These include tests of blood vessel function, measurements of specific proteins related to brain and kidney damage, and markers of inflammation and blood clotting. Researchers will monitor how well the blood vessels respond and measure injury markers over time to understand the effects of vericiguat. Participation will last through the immediate perioperative period with careful monitoring of outcomes and safety.
CONDITIONS
Brief Title
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Scheduled for elective open-heart surgery involving sternotomy or thoracotomy
You will not qualify if you...
- Intolerance to vericiguat
- Current use of other soluble guanylyl cyclase stimulators or phosphodiesterase-5 inhibitors
- Pregnancy or breastfeeding
- 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 for major congenital heart defect
- Use of extracorporeal membrane oxygenation before surgery
- Active systemic infection or surgery for infectious endocarditis
- Ventricular assist device or intraaortic balloon pump support before surgery
- Prisoners
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants take the assigned oral medication (vericiguat or placebo) once daily starting 2 days prior to their elective cardiac surgery.
1 to 2 visits before surgery
Duration - Day of surgery
Participants continue the assigned oral medication on the day of surgery while vascular function assessments and blood and urine samples are collected to measure markers of organ injury.
1 surgery day visit (in-person)
Duration - 3 days
Participants are monitored for organ injury markers and vascular function through postoperative day 2.
Up to 3 visits (in-person) through postoperative day 2
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
Actively Recruiting
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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