SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanderbilt University Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years
Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
Disqualifiers
Intolerance to vericiguat
Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors
Pregnancy or breast feeding. Pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test
Renal replacement therapy within 30 days prior to screening
Trial design
Treatments tested in this trial
- Vericiguat
- Placebo
Treatment groups
170 Participants
are divided into 2 treatment groupsSponsors and collaborators
Vanderbilt University Medical Center
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov