Endothelial DysfunctionPhase 4SOLSTICENCT05812755
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
A Phase 4 study testing Vericiguat in people with Endothelial Dysfunction and Vascular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction, Vascular Diseases, Kidney Injury
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2023to Jul 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
Who cannot join
- 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
- Estimated glomerular filtration rate <15 ml/min per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening
- Systolic blood pressure less than 120 mmHg at the time of screening
Show all 14Show fewer
- Prior kidney transplantation
- History of significant liver dysfunction (defined as Child-Pugh class C)
- Surgery scheduled to be performed with circulatory arrest
- Surgery scheduled to correct a major congenital heart defect
- Extracorporeal membrane oxygenation (ECMO) prior to surgery
- Active systemic infection or surgery for infectious endocarditis
- Ventricular assist device or intraaortic balloon pump support prior to surgery
- Prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37204
Marcos G Lopez, MD, 615-936-5894, marcos.g.lopez@vumc.org
About this study
Official title: The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery
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:
- Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo?
- Does soluble guanylyl cyclase stimulation decrease markers of kidney injury and brain injury compared to placebo?
Read more
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.
Read the 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
- Being tested
- Vericiguat, Placebo
- Medical subject headings
- Vascular Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery
PlaceboDrug
Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat | Active comparator | 10 mg vericiguat administered orally once daily for three days (through day of surgery) Receives: Drug: Vericiguat |
| Placebo | Placebo comparator | placebo administered orally once daily for three days (through day of surgery) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Day of surgery
Ex vivo vascular relaxation
Ex vivo arterial relaxation (percent) in participants with available vascular tissue (Aim 1 primary outcome)
Measured: 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)
Measured: 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)
Measured: Enrollment through postoperative day 2
Secondary outcomes (4)
Phosphorylated vasodilator stimulated phosphoprotein (phospho-VASP)
Soluble guanylyl cyclase stimulation will be further quantified as arterial phospho-VASP/VASP ratio(Aim 1 secondary outcome)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Enrollment through postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start19 May 2023
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Marcos G. Lopez, Vanderbilt University Medical Center
- Investigators
- Marcos Lopez, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812755
- Sponsor's protocol ID
- 222089
- Other IDs
- R01HL164909
- Acronym
- SOLSTICE
- Status last verified
- Aug 2026
- First submitted
- 28 Mar 2023
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05812755
- Acronym / sponsor ID
- SOLSTICE / 222089
- Conditions
- Endothelial Dysfunction, Vascular Diseases, Kidney Injury, Brain Disease, Vascular Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 19 May 2023 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 14 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does soluble guanylyl cyclase stimulation improve blood vessel function compared to placebo?
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat | Active comparator | Drug: Vericiguat10 mg vericiguat administered orally once daily for three days (through day of surgery) |
| Placebo | Placebo comparator | Drug: Placeboplacebo administered orally once daily for three days (through day of surgery) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥18 years
- Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
Key exclusion criteria (14 listed)
- 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
- Estimated glomerular filtration rate <15 ml/min per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatVericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery | Drug | Vericiguat |
| PlaceboMatched placebo administered orally starting 2 days prior to heart surgery through the day of surgery | Drug | Placebo |
Primary outcome
Brachial artery flow-mediated dilation
Time frame: Day of surgery
Percent change in brachial artery diameter from baseline to maximum post-forearm ischemia adjusted for shear-rate (Aim 1 primary outcome).
Ex vivo vascular relaxation
Time frame: Day of surgery
Ex vivo arterial relaxation (percent) in participants with available vascular tissue (Aim 1 primary outcome)
Ubiquitin C-terminal hydrolase L1 (UCHL1) plasma concentration
Time frame: Enrollment through postoperative day 2
UCHL1 will be measured in plasma to quantify effects of vericiguat vs. placebo on neuronal injury (Aim 2 primary neuronal outcome)
Neutrophil gelatinase associated lipocalin (NGAL) urine concentration
Time frame: Enrollment through postoperative day 2
NGAL will be measured in urine to quantify effects of vericiguat vs. placebo on markers of renal injury (Aim 2 primary renal outcome)
4 secondary outcomes
Phosphorylated vasodilator stimulated phosphoprotein (phospho-VASP)
Time frame: Enrollment through postoperative day 2
Endothelial barrier breakdown - claudin-5
Time frame: Enrollment through postoperative day 2
Endothelium mediated inflammation and coagulation - plasminogen activator inhibitor-1 (PAI-1)
Time frame: Enrollment through postoperative day 2
Endothelial Activation - intercellular adhesion molecule 1 (ICAM1)
Time frame: Enrollment through postoperative day 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marcos Lopez, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vericiguat in people with Endothelial Dysfunction and Vascular Diseases, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brachial artery flow-mediated dilation (time frame: Day of surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.