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Vericiguat for Vascular Function and Organ Injury in Heart Surgery Patients (SOLSTICE Trial)
Phase 4
Recruiting
Led By Marcos Lopez, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months postoperatively
Awards & highlights
SOLSTICE Trial Summary
This trial will investigate if a drug can improve vascular function & reduce markers of kidney & brain injury in heart surgery patients.
Who is the study for?
This trial is for adults over 18 who are scheduled for elective open-heart surgery. It's not suitable for those with severe kidney issues, low blood pressure, liver dysfunction, or on certain medications like phosphodiesterase-5 inhibitors. Pregnant or breastfeeding individuals and prisoners are also excluded.Check my eligibility
What is being tested?
The study tests if vericiguat, a drug that stimulates soluble guanylyl cyclase (SGC), can improve blood vessel function and reduce brain and kidney injury markers after heart surgery compared to a placebo. Participants will be randomly assigned to either the drug or placebo group.See study design
What are the potential side effects?
While specific side effects of vericiguat in this context aren't detailed here, SGC stimulators may cause headaches, dizziness, indigestion or heartburn. Side effects vary by individual and should be monitored closely during the trial.
SOLSTICE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for open-heart surgery that involves opening my chest.
Select...
I am 18 years old or older.
SOLSTICE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Brachial artery flow-mediated dilation
Ex vivo vascular relaxation
Neutrophil gelatinase associated lipocalin (NGAL) urine concentration
+1 moreSecondary outcome measures
Endothelial Activation - intercellular adhesion molecule 1 (ICAM1)
Endothelial barrier breakdown - claudin-5
Endothelium mediated inflammation and coagulation - plasminogen activator inhibitor-1 (PAI-1)
+1 moreOther outcome measures
Exploratory clinical outcome: Arrythmia
Exploratory clinical outcome: Death
Exploratory clinical outcome: Hospital length of stay
+11 moreSOLSTICE Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: VericiguatActive Control1 Intervention
10 mg vericiguat administered orally once daily for three days (through day of surgery)
Group II: PlaceboPlacebo Group1 Intervention
placebo administered orally once daily for three days (through day of surgery)
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
857 Previous Clinical Trials
672,023 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,840 Previous Clinical Trials
47,851,954 Total Patients Enrolled
2 Trials studying Vasculitis
37 Patients Enrolled for Vasculitis
Marcos Lopez, MDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for open-heart surgery that involves opening my chest.I am not taking any medication that affects blood vessel dilation.My kidney function is severely reduced.I am 18 years old or older.I have an ongoing infection or had surgery for heart infection.I have had ECMO treatment before surgery.My surgery will involve stopping my blood circulation.I am scheduled for surgery to fix a major birth heart defect.I have not undergone kidney replacement therapy in the last 30 days.I have used a heart pump or balloon pump support before surgery.Your blood pressure is lower than 120 mmHg when checked.You have had a bad reaction to vericiguat.I have had a kidney transplant.I do not have severe liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Vericiguat
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential risks has Vericiguat been linked to?
"There is a significant amount of data attesting to the safety of Vericiguat, so it received an assessment score of 3."
Answered by AI
Are there any opportunities available for participants to join this experiment?
"Unfortunately, the details listed on clinicaltrials.gov confirm that this investigation is no longer recruiting new patients; it was first posted April 1st 2023 and last updated 11 days later. However, there are 1423 other trials presently looking for participants at present."
Answered by AI
What is the ultimate aim of this experimental procedure?
"The primary objective of this trial, to be assessed on the day of surgery, is Ex vivo vascular relaxation. To further support this aim and assess more detailed outcomes, Endothelial barrier breakdown - claudin-5 (plasma concentration), Endothelium mediated inflammation and coagulation - plasminogen activator inhibitor-1 (PAI-1) (plasma concentration), and Endothelial Activation - intercellular adhesion molecule 1 (ICAM1) will all also be quantified."
Answered by AI
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