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

Study acronym: SOLSTICE
StatusRecruiting
PhasePhase 4
Started2023-05-19
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 18 months later Dec 2026 → Jul 2028
See other at-risk trials from Vanderbilt University Medical Center

Amendment history

2026-08-03
Study Status, Outcome Measures v6
Primary completion pushed: 2026-12 → 2028-07
Completion pushed: 2027-11 → 2029-07
2025-07-02
Study Status v5
Primary completion date2026-10→2026-12
2024-06-26
2 amendments v3-v4
2 re-verifications since 2023-07-05, no change to tracked fields
2023-05-22
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2023-05→2023-05-19
Study sitesdetails revised at 1 of 1 site
2023-05-08
Study Status v1
Start date2023-04→2023-05
2023-04-11
Original filing
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.
Trial Details
NCT Number NCT05812755
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Endothelial Dysfunction, Vascular Diseases, Kidney Injury, Brain Disease, Vascular Inflammation
Enrollment 170 participants
Start Date 2023-05-19
Primary Completion 2028-07 (estimated)
Study Completion 2029-07 (estimated)
Updated on ClinicalTrials.gov 2026-08-06