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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05812755
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 19, 2023
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Vericiguat
    10 mg vericiguat administered orally once daily for three days (through day of surgery)
  • Placebo Comparator: Placebo
    placebo administered orally once daily for three days (through day of surgery)

Primary Outcome Measure

Brachial artery flow-mediated dilation [ Time Frame: Day of surgery ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37204
Marcos G Lopez, MD
[email protected]
615-936-5894

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By research site
Vanderbilt University Medical Center· Nashville, TN

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