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Recruiting NCT05812755

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

Phase IV Interventional Endothelial Dysfunction Vascular Diseases Kidney Injury Brain Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vericiguat, Placebo.
Who it may be relevant to
Registry conditions: Endothelial Dysfunction, Vascular Diseases, Kidney Injury, Brain Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Interventions

  • Drug Vericiguat
    Vericiguat 10 mg administered orally starting 2 days prior to heart surgery through the day of surgery
  • Drug Placebo
    Matched placebo administered orally starting 2 days prior to heart surgery through the day of surgery

Primary outcome measures

  • Brachial artery flow-mediated dilation [Time frame: Day of surgery]
  • Ex vivo vascular relaxation [Time frame: Day of surgery]
  • Ubiquitin C-terminal hydrolase L1 (UCHL1) plasma concentration [Time frame: Enrollment through postoperative day 2]
  • Neutrophil gelatinase associated lipocalin (NGAL) urine concentration [Time frame: Enrollment through postoperative day 2]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Elective open-heart surgery, defined as surgery on the heart or aorta that requires sternotomy or thoracotomy

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT05812755 · 222089 · R01HL164909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗