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

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called vericiguat, which stimulates a specific enzyme in the body, affects blood vessel function and reduces injury to the kidneys and brain in patients undergoing heart surgery. Researchers want to find out if using vericiguat can improve the way blood vessels work and lower the levels of certain markers that indicate kidney and brain injury compared to a placebo, which is an inactive substance.

To participate in this study, individuals must be at least 18 years old and scheduled for elective open-heart surgery, which involves making an incision in the chest to access the heart or aorta. However, some people may not be eligible, such as those who have recently undergone kidney treatment, are pregnant, or have certain serious health conditions. Participants will be randomly assigned to receive either vericiguat or a placebo, and they will be monitored to see how well their blood vessels function and if there are any changes in kidney and brain injury markers. This trial will help researchers understand more about why some patients experience kidney and brain problems after heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years
• • 2. Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
• Exclusion Criteria:
• • 1. Intolerance to vericiguat
• • 2. Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors
• • 3. Pregnancy or breast feeding. Pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test
• • 4. Renal replacement therapy within 30 days prior to screening
• • 5. Estimated glomerular filtration rate \<15 ml/min per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening
• • 6. Systolic blood pressure less than 120 mmHg at the time of screening
• • 7. Prior kidney transplantation
• • 8. History of significant liver dysfunction (defined as Child-Pugh class C)
• • 9. Surgery scheduled to be performed with circulatory arrest
• • 10. Surgery scheduled to correct a major congenital heart defect
• • 11. Extracorporeal membrane oxygenation (ECMO) prior to surgery
• • 12. Active systemic infection or surgery for infectious endocarditis
• • 13. Ventricular assist device or intraaortic balloon pump support prior to surgery
• • 14. Prisoners