Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812755
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2023-03-28
Brief Title:
SGC Stimulation Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
The Effects of Soluble Guanylyl Cyclase Stimulation on Perioperative Vascular Reactivity and Organ Injury in Cardiac Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOLSTICE
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL164909 | NIH | None | httpsreporternihgovquickSearchR01HL164909 |