A Phase 4 interventional study of Vericiguat and Placebo in Endothelial Dysfunction, Vascular Diseases and Kidney Injury, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Basic science
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:
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.
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.
694 studies on the registry are indexed under Vascular Diseases; 128 are open to participants now.
This study's planned enrollment of 170 is above the median of 96 across 419 interventional studies indexed under Vascular Diseases.
Browse Vascular Diseases studies →Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mg vericiguat administered orally once daily for three days (through day of surgery)
Drug: Vericiguat
placebo administered orally once daily for three days (through day of surgery)
Drug: Placebo
Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery
Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery
Brachial artery flow-mediated dilation
Percent change in brachial artery diameter from baseline to maximum post-forearm ischemia adjusted for shear-rate (Aim 1 primary outcome).
Time frame: Day of surgery
Ex vivo vascular relaxation
Ex vivo arterial relaxation (percent) in participants with available vascular tissue (Aim 1 primary outcome)
Time frame: Day of surgery
Ubiquitin C-terminal hydrolase L1 (UCHL1) plasma concentration
UCHL1 will be measured in plasma to quantify effects of vericiguat vs. placebo on neuronal injury (Aim 2 primary neuronal outcome)
Time frame: Enrollment through postoperative day 2
Neutrophil gelatinase associated lipocalin (NGAL) urine concentration
NGAL will be measured in urine to quantify effects of vericiguat vs. placebo on markers of renal injury (Aim 2 primary renal outcome)
Time frame: Enrollment through postoperative day 2
Phosphorylated vasodilator stimulated phosphoprotein (phospho-VASP)
Soluble guanylyl cyclase stimulation will be further quantified as arterial phospho-VASP/VASP ratio(Aim 1 secondary outcome)
Time frame: Enrollment through postoperative day 2
Endothelial barrier breakdown - claudin-5
Endothelial barrier breakdown will be quantified as plasma concentration of claudin-5 (Aim 1 secondary outcome)
Time frame: Enrollment through postoperative day 2
Endothelium mediated inflammation and coagulation - plasminogen activator inhibitor-1 (PAI-1)
Endothelium mediated inflammation and coagulation will be quantified as plasma concentration of PAI-1 (Aim 1 secondary outcome)
Time frame: Enrollment through postoperative day 2
Endothelial Activation - intercellular adhesion molecule 1 (ICAM1)
Endothelial activation will be quantified as plasma concentrations of ICAM1 (Aim 1 secondary outcome)
Time frame: Enrollment through postoperative day 2
Exploratory clinical outcome: serum creatinine
Serum creatinine
Time frame: Postoperative day 0 up to 1 year postoperatively (e.g., approximately 1 year after the day of surgery)
Exploratory clinical outcome: Kidney Disease Improving Global Outcomes (KDIGO) Acute Kidney Injury (AKI)
Incidence of KDIGO creatinine criteria AKI
Time frame: Postoperative day 0 up to 1 year postoperatively (e.g., approximately 1 year after the day of surgery)
Exploratory clinical outcome: delirium
Incidence (percent of participants) with a positive delirium exam measured using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time frame: Postoperative day 0 to 10 days postoperatively
Exploratory clinical outcome: delirium severity
Severity of delirium measured using the CAM-ICU-7 score for at least 3 days postoperatively up to 10 days postoperatively for participants who remain in ICU. This is a 7 point scale score with higher scores indicating higher severity of delirium
Time frame: Postoperative day 0 to 10 days postoperatively
Exploratory clinical outcome: Infection
Infection defined as initiation of antibiotics postoperatively not part of perioperative antibiotic prophylaxis.
Time frame: Postoperative day 0 to 10 days postoperatively
Exploratory clinical outcome: Respiratory failure
Respiratory failure defined as the need for mechanical ventilation
Time frame: Postoperative day 0 to hospital discharge (e.g., up to approximately 30 days following surgery)
Exploratory clinical outcome: Thrombocytopenia
Thrombocytopenia defined at platelet count less than 50,000
Time frame: Postoperative day 0 to hospital discharge(e.g., up to approximately 30 days following surgery)
Exploratory clinical outcome: Arrythmia
Arrhythmia defined the onset of new atrial or ventricular dysrhythmia
Time frame: Postoperative day 0 to hospital discharge (e.g., up to approximately 30 days following surgery)
Exploratory clinical outcome: Intensive care unit (ICU) length of stay
ICU length of stay in days
Time frame: Postoperative day 0 to until discharge from the ICU (e.g. up to approximately 10 days following surgery)
Exploratory clinical outcome: Hospital length of stay
Hospital length of stay in days
Time frame: Postoperative day 0 to hospital discharge (e.g., up to approximately 30 days following surgery)
Exploratory clinical outcome: Death
Mortality measured up to one year
Time frame: Postoperative day 0 to one year postoperatively
Exploratory cognitive status outcome: Telephone interview for cognitive status
Six-month follow-up (Telephone Interview for Cognitive Status) obtained by phone interview. Maximum score is 41 and lower score indicates worse cognitive function.
Time frame: 6 months postoperatively
Exploratory functional status outcome: Katz Activities of Daily Living (ADL) assessment
Activities of daily living will be assessed with the Katz ADL assessment via phone interview. This survey assesses independence in 6 activities, and will be summarized as the average number of independent activities.
Time frame: 6 months postoperatively
Exploratory functional status outcome: Pfeffer functional activities questionnaire
Activities of daily living will be assessed with the Pfeffer functional activities questionnaire via phone interview. Maximum score is 30. A score of greater than 9 indicates impaired function and possible cognitive impairment.
Time frame: 6 months postoperatively
Exploratory outcome: microvascular perfusion
A subset of participants will have sublingual assessment of the microcirculation with incident dark field imaging
Time frame: From anesthesia induction to postoperative day 1
Plan to share: No
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Studies of the drug tested here: Vericiguat
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