RECRUITING

SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery

Quick Facts

Study Start:2023-05-19
Study Completion:2027-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05812755

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years
  2. 2. Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy
  1. 1. Intolerance to vericiguat
  2. 2. Use of other soluble guanylyl cyclase stimulators or current use of phosphodiesterase-5 inhibitors
  3. 3. Pregnancy or breast feeding. Pregnancy will be excluded in women of child-bearing potential by a urine or serum beta hcg test
  4. 4. Renal replacement therapy within 30 days prior to screening
  5. 5. Estimated glomerular filtration rate \<15 ml/min per 1.73 m2 per Chronic Kidney Disease Epidemiology collaboration (CKD-EPI) equation at time of screening
  6. 6. Systolic blood pressure less than 120 mmHg at the time of screening
  7. 7. Prior kidney transplantation
  8. 8. History of significant liver dysfunction (defined as Child-Pugh class C)
  9. 9. Surgery scheduled to be performed with circulatory arrest
  10. 10. Surgery scheduled to correct a major congenital heart defect
  11. 11. Extracorporeal membrane oxygenation (ECMO) prior to surgery
  12. 12. Active systemic infection or surgery for infectious endocarditis
  13. 13. Ventricular assist device or intraaortic balloon pump support prior to surgery
  14. 14. Prisoners

Contacts and Locations

Principal Investigator

Marcos Lopez, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37204
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Marcos Lopez, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-19
Study Completion Date2027-11

Study Record Updates

Study Start Date2023-05-19
Study Completion Date2027-11

Terms related to this study

Additional Relevant MeSH Terms

  • Endothelial Dysfunction
  • Vascular Diseases
  • Kidney Injury
  • Brain Disease
  • Vascular Inflammation