- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07468292
GARDE : GC7 (N1-guanyl-1,7 Diaminoheptane) cARDiac arrEst (GARDE)
March 12, 2026 updated by: Centre Hospitalier Universitaire de Nice
Impact of GC7 (N1-guanyl-1,7 Diaminoheptane) on Oxidative Stress in Patients Who Have Experienced a Resuscitated Cardiorespiratory Arrest
Cardiac arrest (CA) with return of spontaneous circulation is associated with high mortality, exceeding 90% in out-of-hospital settings and approaching 50% in in-hospital settings.
Despite management of the underlying cause of CA, patients often die from post-anoxic brain injury or from ischemia-reperfusion injury occurring after reperfusion and reoxygenation, which increases oxidative stress and leads to multi-organ failure.
To date, no effective therapeutic strategy has been established in humans to limit these ischemia-reperfusion injuries.
GC7 (N1-guanyl-1,7 diaminoheptane) has demonstrated a strong protective potential against ischemia reperfusion injury in rodent and porcine models, including myocardial infarction, stroke, and renal transplantation.
These protective effects are attributed to the pleiotropic action of GC7 which renders cells and tissues energetically less dependent on oxygen, and reduces oxidative stress which play a major role in ischemia reperfusion injury.
Degree of blood acidification and immune dysregulation may also represent parameters that GC7 could potentially influence.
Although no adverse effects have been reported in these experimental models, GC7 has not yet been studied in human.
Our study therefore aims to demonstrate the protective effect of GC7 on blood cells in patients after CA by evaluating oxidative stress levels, blood acidification and inflammatory profile.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Denis Doyen, MD
- Phone Number: +33492033615
- Email: doyen.d@chu-nice.fr
Study Contact Backup
- Name: DOMINIQUE DONZEAU
- Phone Number: +33492034560
- Email: donzeau.d@chu-nice.fr
Study Locations
-
-
-
Nice, France
- CHU de Nice - Hôpital Pasteur 2
-
Contact:
- Denis Doyen, MD
- Phone Number: +33492033615
- Email: doyen.d@chu-nice.fr
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Cardiac arrest as the primary reason for hospital admission
- Admission < 48 hours
- Age ≥ 18 years
- Affiliated with a social security system
Exclusion Criteria:
- Limitation or withdrawal of life-sustaining therapies prior to study screening
- Prior cardio-vascular ischemic event (> 24h) before cardiac arrest
- Patient deprived of liberty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: resuscitated cardiorespiratory arrest
|
24-hour exposure of patient 's blood to GC7 molecule
No exposure of blood to GC7 molecule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood oxidative stress levels
Time Frame: at 24 hours after blood exposure to GC7
|
at 24 hours after blood exposure to GC7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood acidification
Time Frame: 24 hours after blood exposure to GC7
|
24 hours after blood exposure to GC7
|
|
Blood inflammatory profile
Time Frame: 24 hours after blood exposure to GC7
|
24 hours after blood exposure to GC7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 9, 2026
First Posted (Actual)
March 12, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 12, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-AOIP-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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