NCT05812755

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

The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients undergoing elective cardiac surgery will be randomized to the soluble guanylyl cyclase stimulator vericiguat versus placebo before surgery through the day of surgery and vascular function will be quantified using ultrasound and direct assessment of arterial relaxation ex-vivo. Markers of brain and kidney injury will be measured in plasma and urine.

Conditions

• Endothelial Dysfunction
• Vascular Diseases
• Kidney Injury
• Brain Disease
• Vascular Inflammation

Interventions

Type	Name	Description
DRUG	Vericiguat	Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery
DRUG	Placebo	Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery

Timeline

• Start date: 2023-05-19
• Primary completion: 2026-12-01
• Completion: 2027-11-01
• First posted: 2023-04-14
• Last updated: 2025-07-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study