Not yet recruitingNCT07868757FRENSHOCK 2Updated Oct 9, 2026

French Observatory on the Management of Cardiogenic Shock 2

An observational study in Cardiogenic Shock, sponsored by French Cardiology Society. Not yet recruiting at 2 sites in France. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2026-10-09.

Sponsored by French Cardiology Society · Observational

Updated Oct 9, 2026Newly registeredGo to Updates ↓

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 1,000
Ages: 0 Days and older
Sex: All

Study 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.

Conditions studied

Cardiogenic Shock

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Keywords

heart disease
shock
Cardiogenic shock

In context

Shock, Cardiogenic

281 studies on the registry are indexed under Shock, Cardiogenic; 128 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 180 across 146 observational studies indexed under Shock, Cardiogenic.

Browse Shock, Cardiogenic studies →

Lead sponsor

French Cardiology Society is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 0 Days and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Adult or pediatric patients presenting with cardiogenic shock

Eligibility criteria

Adult Inclusion Criteria:

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:
1. 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
2. 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
3. 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

Pediatric inclusion criteria :

Children must meet a revised and age-adapted FRENSHOCK definition of cardiogenic shock as described below, taking into account age- and/or weight-specific normal values (blood pressure, cardiac output, and urine output).

Parent(s) or legal guardian(s) having provided explicit consent for the use of the child's National Health Identifier (NIR) for research purposes. The child will receive information appropriate to their age and level of understanding.
Patients covered by a national health insurance scheme.
Patients with cardiogenic shock, defined as meeting at least one positive criterion in each of the following three categories:
1. Low cardiac output, defined by at least one of the following:
  - Clinical: systolic blood pressure below the 5th percentile for age and height and/or requirement for inotropic or vasopressor support
  - Echocardiography: cardiac index \< 2.2 L/min/m² or left ventricular ejection fraction (LVEF) \< 50%
2. Elevated pulmonary filling pressures/left-sided 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: pulmonary congestion on chest radiography or chest CT scan, or diffuse bilateral B-lines on lung ultrasound
  - Echocardiography: elevated right- and/or left-sided filling pressures according to current guideline recommendations
3. End-organ hypoperfusion, defined by at least one of the following:
  - Clinical: new-onset oliguria, defined as urine output \< 1 mL/kg/h in children younger than 2 years and \< 0.5 mL/kg/h in children aged 2 years or older, 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

Adult exclusion criteria :

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.
Refusal to participate or failure to implement the emergency inclusion procedure when required.

Pediatric exclusion criteria :

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.
Refusal of participation by the parent(s) or legal guardian(s), or failure to implement the emergency inclusion procedure when required.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 1,000 participants (estimated)
Patient registry: No

Groups and cohorts

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

What researchers measure

Primary outcomes

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.
Time frame: 30 days

Secondary outcomes

Use of in-hospital organ support therapies
Number and percentage of patients who received renal replacement therapy (dialysis), invasive or non-invasive mechanical ventilation, or acute circulatory support (ECMO, Impella, IABP, or other mechanical circulatory support devices) during the index hospitalization.
Time frame: Baseline
Cognitive impairment assessed by the Codex test
Time frame: Within 24 hours prior to hospital discharge
Use of long-term treatment for chronic heart failure among hospital discharge survivors
Time frame: Within 24 hours prior to hospital discharge, 1 year, and 5 years
albumin-to-creatinine ratio
Time frame: on admission, Within 24 hours prior to hospital discharge, and at 1 year
NYHA grade
Time frame: 1 year
FEVG
Time frame: 1 year
Number and percentage of patients receiving home hospitalization or admitted to a rehabilitation or palliative care unit
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients followed by a cardiologist and frequency of follow-up
Number and percentage of patients receiving cardiology follow-up and frequency of follow-up visits in the immediate period after the index hospitalization and throughout the 5-year follow-up period.
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients undergoing transthoracic echocardiography and frequency of examinations
Number and percentage of patients who underwent transthoracic echocardiography, and frequency of examinations, in the immediate period after the index hospitalization and throughout follow-up.
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients receiving a LifeWest, pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients undergoing catheter ablation for atrial fibrillation/flutter and/or ventricular tachycardia/fibrillation
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients followed by a nephrologist and frequency of follow-up
Number and percentage of patients receiving nephrology follow-up and frequency of follow-up visits in the immediate period after the index hospitalization and throughout the 5-year follow-up period.
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients receiving chronic hemodialysis and type of hemodialysis
Number and percentage of patients who underwent one or more chronic hemodialysis sessions, and type of hemodialysis received, in the immediate period after the index hospitalization and throughout follow-up.
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of hospital discharge survivors receiving chronic dialysis
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients receiving durable mechanical circulatory support (LVAD, BiVAD, or TAH) or undergoing heart transplantation
Number and percentage of patients receiving durable mechanical circulatory support (left ventricular assist device \[LVAD\], biventricular assist device \[BiVAD\], or total artificial heart \[TAH\]) or undergoing heart transplantation.
Time frame: 30 days, 1 year, 5 years
Number and percentage of hospital discharge survivors rehospitalized for heart failure
Number and percentage of hospital discharge survivors with at least one rehospitalization for heart failure during follow-up.
Time frame: 1 year, 5 years
All-cause and cardiovascular mortality at 30 days, 1 year and 5 years
Time frame: 30 days, 1 year and 5 years
Socioeconomic deprivation assessed by FDep indices
Socioeconomic deprivation assessed using the French Deprivation Index (FDep) derived from INSEE territorial units (municipalities and IRIS areas).
Time frame: Baseline
Socioeconomic deprivation assessed by F-EDI indices
Socioeconomic deprivation assessed using the French European Deprivation Index (F-EDI) derived from INSEE territorial units (municipalities and IRIS areas).
Time frame: baseline

Study locations

2 sites

CHU Nouvel Hôpital Civil
Strasbourg, 67000, France
- Hamid MERDJI, MD · Contact · frenshock2@sfardio.fr · 01 44 90 70 28
Hôpital Rangueil
Toulouse, 31400, France
- Clément DELMAS, MD · Contact · frenshock2@sfardio.fr · 01 44 90 70 28

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2027; primary completion for Feb 2028, 13 months later.

Of 73 non-industry observational studies under Shock, Cardiogenic, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 27. This study's planned 13 months is below that.

Counting every sponsor, half of 77 studies reached it within 54 months; a quarter within 27.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 24, 2026
First posted: Oct 9, 2026
StartEst.: Jan 2027
Primary completionEst.: Feb 2028
CompletionEst.: Jan 2033
Last update: Oct 9, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Registered

First appeared on the registry. No changes since

Oct 9, 2026

Show all 1 update

Oct 9, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07868757
Lead sponsor: French Cardiology Society
Responsible party: Sponsor
First posted: Oct 9, 2026
Start date: Jan 2027 (estimated)
Primary completion: Feb 2028 (estimated)
Completion: Jan 2033 (estimated)
Last update: Oct 9, 2026

Study contacts

Clément DELMAS, MD

Contact

frenshock2@sfardio.fr

01 44 90 70 28 ext. +33

Hamid MERDJI, MD

Contact

frenshock2@sfardio.fr

01 44 90 70 28 ext. +33

Clément DELMAS, MD

principal investigator · Hôpital Rangueil

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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