SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
NCT05812755 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2025-07-08
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.
Conditions
- Endothelial Dysfunction
- Vascular Diseases
- Kidney Injury
- Brain Disease
- Vascular Inflammation
Interventions
- DRUG
-
Vericiguat
Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery
- DRUG
-
Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Vanderbilt University Medical Center
lead OTHER
Principal Investigators
-
Marcos Lopez, MD · Vanderbilt University Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-19
- Primary Completion
- 2026-12-31
- Completion
- 2027-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Investigation of Myocardial Protection Level With Specific Cardioplegia Methods in Cardiac Surgery
NCT05603429 ·Status: COMPLETED
-
Study of Myocardial Contractility After Cardiac Surgery Under an Anterograde or Retrograde Cardioplegia
NCT02816385 ·Status: COMPLETED ·Phase: NA
-
Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Cardiac Surgery
NCT03574311 ·Status: UNKNOWN ·Phase: PHASE4
-
Biobank Cardiac Surgery
NCT06747806 ·Status: RECRUITING
-
Biologically Modified Saphenous Vein Transplants for Improved CABG Outcomes
NCT01313533 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Effects of Colloid and Crystalloid on the Microcirculatory Alterations During Off-pump Coronary Artery Bypass Surgery
NCT01713166 ·Status: COMPLETED ·Phase: NA
-
Microcirculation in Cardiac Surgery
NCT01330745 ·Status: TERMINATED ·Phase: NA
-
Thiamine Supplementation in High Risk Cardiac Surgery Patients
NCT03306732 ·Status: COMPLETED ·Phase: PHASE4
-
Safety & Efficacy of BCT197 in Patients Undergoing Cardiac Surgery
NCT01336959 ·Status: TERMINATED ·Phase: PHASE2
-
Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients
NCT02757443 ·Status: COMPLETED ·Phase: PHASE3
-
Coronary Artery Bypass and Nitrate Oral Supplementation
NCT01348971 ·Status: COMPLETED ·Phase: PHASE2
-
Short-term Endothelin A Receptor Blockade in Patients With On-pump CABG
NCT01658410 ·Status: UNKNOWN ·Phase: PHASE2
-
Nitric Oxide in Cardiopulmonary Bypass for Renal Protection in Cardiac Surgery
NCT03527381 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Outcomes Study of Glycosylated Hemoglobin Control in Cox-Maze IV During Cardiac Surgery
NCT05374655 ·Status: UNKNOWN ·Phase: NA
-
Study of Microcirculation During Extracorporeal Circulation in Cardiac Surgery
NCT04058860 ·Status: COMPLETED ·Phase: NA
-
Nitrite Effects on Cardiac Muscle in CABG
NCT04001283 ·Status: UNKNOWN ·Phase: PHASE2
-
Angiopoietin and Adverse Outcomes in Cardiac Surgery
NCT05817929 ·Status: RECRUITING ·Phase: NA
-
Nitric Oxide for Reduced Intensive Support in Cardiac Surgery With Cardiopulmonary Bypass
NCT06702553 ·Status: RECRUITING ·Phase: PHASE3
-
Expression of Angiogenic Factors in Myocardial Tissue
NCT01414621 ·Status: COMPLETED
-
High Dose Vitamin C in Cardiac Surgery Patients
NCT02762331 ·Status: TERMINATED ·Phase: PHASE1
-
Preconditioning With Hyperbaric Oxygen in Cardiovascular Surgery
NCT00817791 ·Status: COMPLETED ·Phase: NA
-
Alpha Ketoglutarate Enhances Geroprotection In Surgery (AEGIS)
NCT07031128 ·Status: RECRUITING ·Phase: PHASE4
-
The Effect of Colchicine on the Occurrence of Atrial Fibrillation After Cardiac Surgery
NCT06798714 ·Status: RECRUITING ·Phase: PHASE4
-
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
NCT00252200 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of NU172 as Anticoagulation in Patients Undergoing Off-pump CABG Surgery
NCT00808964 ·Status: UNKNOWN ·Phase: PHASE2