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

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

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