Recruiting

SGC Stimulation

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05812755

Conditions

Endothelial Dysfunction

Vascular Diseases

Kidney Injury

Brain Disease

Vascular Inflammation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vericiguat

Placebo

Study Details

Brief 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.

Conditions

Endothelial Dysfunction

Vascular Diseases

Kidney Injury

Brain Disease

Vascular Inflammation

Study ID

NCT05812755

Start date

May 19, 2023

Status verified date

Aug, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Vericiguat

10 mg vericiguat administered orally once daily for three days (through day of surgery)

placebo comparator: Placebo

placebo administered orally once daily for three days (through day of surgery)

Interventions

Vericiguat

Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery

Placebo

Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery

Primary outcome measure

  • Brachial artery flow-mediated dilation [ Time Frame: Day of surgery ]
  • Ex vivo vascular relaxation [ Time Frame: Day of surgery ]
  • Ubiquitin C-terminal hydrolase L1 (UCHL1) plasma concentration [ Time Frame: Enrollment through postoperative day 2 ]
  • Neutrophil gelatinase associated lipocalin (NGAL) urine concentration [ Time Frame: Enrollment through postoperative day 2 ]

Central Contacts and Locations

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37204

Contacts

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-08-06.