NCT07468292

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
29mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 9, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

cardiac arrestGC7 (N1-guanyl-1,7 diaminoheptane)oxidative stress

Outcome Measures

Primary Outcomes (1)

  • Blood oxidative stress levels

    at 24 hours after blood exposure to GC7

Secondary Outcomes (2)

  • Blood acidification

    24 hours after blood exposure to GC7

  • Blood inflammatory profile

    24 hours after blood exposure to GC7

Study Arms (1)

resuscitated cardiorespiratory arrest

EXPERIMENTAL
Other: GC7 exposureOther: No GC7 exposure

Interventions

24-hour exposure of patient 's blood to GC7 molecule

resuscitated cardiorespiratory arrest

No exposure of blood to GC7 molecule

resuscitated cardiorespiratory arrest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiac arrest as the primary reason for hospital admission
  • Admission \< 48 hours
  • Age ≥ 18 years
  • Affiliated with a social security system

You may not qualify if:

  • Limitation or withdrawal of life-sustaining therapies prior to study screening
  • Prior cardio-vascular ischemic event (\> 24h) before cardiac arrest
  • Patient deprived of liberty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Hôpital PASTEUR 2

Nice, France

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Denis DOYEN, MD

CONTACT

DOMINIQUE DONZEAU

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 12, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Locations