Effects of a medication on blood vessel function and organ injury in heart surgery patients
The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery
This study tests if a medication called vericiguat can improve blood vessel function and reduce kidney and brain injury in patients having heart surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05812755 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a medication called vericiguat, a soluble guanylyl cyclase stimulator, on vascular function and markers of kidney and brain injury in patients undergoing elective cardiac surgery. Participants will be randomly assigned to receive either vericiguat or a placebo, and their vascular function will be assessed using ultrasound and direct arterial relaxation tests. Additionally, researchers will measure markers of kidney and brain injury in plasma and urine to evaluate the medication's effectiveness compared to placebo. The study aims to uncover the mechanisms behind post-surgical kidney and brain function issues.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older scheduled for elective open-heart surgery.
Not a fit: Patients with severe renal impairment, significant liver dysfunction, or those undergoing specific types of surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved vascular function and reduced organ injury in patients undergoing heart surgery.
How similar studies have performed: Other studies have shown promise with soluble guanylyl cyclase stimulators in improving vascular function, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Marcos Lopez, MD — Vanderbilt University Medical Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.