NCT07868757

Brief Summary

The aim of this observational study is to describe the baseline characteristics, management strategies, and early outcomes (during hospitalisation and at 30 days) of patients admitted to intensive care with cardiogenic shock, regardless of aetiology. This prospective multicenter registry will enroll consecutive patients admitted to participating adult and pediatric critical care units in France, using current definitions and classifications of cardiogenic shock. The study aims to improve patient characterization and risk stratification and support the development of future interventional studies. 1,000 patients will be enrolled over 12 months, with follow-up at 30 days, 1 year, and through linkage with the French National Health Data System (SNDS) at 1 and 5 years.

Trial Health

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Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
73mo left

Started Jan 2027

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

September 24, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 9, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

October 9, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 24, 2026

Last Update Submit

October 7, 2026

Conditions

Cardiogenic Shock

Keywords

heart diseaseshockCardiogenic shock

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality during hospitalization and at 30 days

    All-cause mortality assessed during the index hospitalization and at 30-day follow-up among patients hospitalized with cardiogenic shock of any etiology, excluding post-cardiotomy cardiogenic shock.

    30 days

Secondary Outcomes (19)

  • Use of in-hospital organ support therapies

    Baseline

  • Cognitive impairment assessed by the Codex test

    Within 24 hours prior to hospital discharge

  • Use of long-term treatment for chronic heart failure among hospital discharge survivors

    Within 24 hours prior to hospital discharge, 1 year, and 5 years

  • albumin-to-creatinine ratio

    on admission, Within 24 hours prior to hospital discharge, and at 1 year

  • NYHA grade

    1 year

  • +14 more secondary outcomes

Study Arms (1)

Patients hospitalized with cardiogenic shock

Consecutive adult and pediatric patients hospitalized with cardiogenic shock of any etiology and enrolled during the index hospitalization.

Eligibility Criteria

Age0 Days+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult or pediatric patients presenting with cardiogenic shock

You may qualify if:

  • Patients covered by a national health insurance scheme.
  • Patients who have provided explicit consent for the use of their National Health Identifier (NIR) for research purposes. If obtaining consent is temporarily impossible due to the patient's clinical condition, the emergency consent procedure described in the protocol will be applied.
  • Patients meeting the FRENSHOCK definition of cardiogenic shock, with at least one positive criterion in each of the three categories below:
  • Low cardiac output, defined by at least one of the following:
  • Clinical: systolic blood pressure (SBP) \< 90 mmHg and/or requirement for inotropic or vasopressor support to maintain SBP \> 90 mmHg
  • Echocardiography: cardiac index (CI) \< 2.2 L/min/m²
  • Hemodynamic assessment using a Swan-Ganz catheter or right heart catheterization: CI \< 2.2 L/min/m²
  • Elevated pulmonary filling pressures/congestion and/or elevated right-sided filling pressures, defined by at least one of the following:
  • Clinical: left-sided and/or right-sided heart failure
  • Imaging: signs of congestion on chest X-ray or chest CT scan, or diffuse bilateral B-lines on lung ultrasound
  • Echocardiography: elevated left and/or right ventricular filling pressures according to current guideline recommendations
  • Right heart catheterization or Swan-Ganz catheterization: pulmonary capillary wedge pressure \> 15 mmHg and/or right atrial pressure \> 8 mmHg
  • End-organ hypoperfusion, defined by at least one of the following:
  • Clinical: new-onset oliguria \< 0.5 mL/kg/h, mottling, altered mental status, or capillary refill time \> 3 seconds
  • Laboratory findings: arterial lactate \> 2 mmol/L and/or ScvO2/SvO2 \< 60% and/or veno-arterial CO2 gap \> 6 mmHg
  • +14 more criteria

You may not qualify if:

  • Final diagnosis other than cardiogenic shock.
  • Unwitnessed and/or prolonged cardiac arrest (estimated low-flow duration \> 30 minutes) and/or absence of return of spontaneous circulation at the time of hospital admission.
  • Post-cardiotomy cardiogenic shock.
  • Individuals deprived of liberty by judicial or administrative decision.
  • Adults under legal protection.
  • Preterm neonates (\< 37 weeks corrected gestational age).
  • Neonates diagnosed with cardiogenic shock at birth, with the exception of fetal or neonatal arrhythmias.
  • Neonates with right-sided cardiogenic shock secondary to persistent pulmonary hypertension of the newborn.
  • Final diagnosis other than cardiogenic shock.
  • Unwitnessed and/or prolonged cardiac arrest (estimated low-flow duration \> 30 minutes) and/or absence of return of spontaneous circulation at the time of hospital admission.
  • Cardiac arrest of non-cardiac origin.
  • Post-cardiotomy cardiogenic shock.
  • Patients not covered by a national health insurance scheme.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Nouvel Hôpital Civil

Strasbourg, 67000, France

Location

Hôpital Rangueil

Toulouse, 31400, France

Location

MeSH Terms

Conditions

Shock, CardiogenicHeart DiseasesShock

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Clément DELMAS, MD

    Hôpital Rangueil

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Clément DELMAS, MD

CONTACT

01 44 90 70 28frenshock2@sfardio.fr

Hamid MERDJI, MD

CONTACT

01 44 90 70 28frenshock2@sfardio.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2026

First Posted

October 9, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

January 1, 2033

Last Updated

October 9, 2026

Record last verified: 2026-09

Locations

FR(2)