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Cardiogenic ShockFRENSHOCK 2NCT07868757

French Observatory on the Management of Cardiogenic Shock 2

An observational study of Cardiogenic Shock, run by French Cardiology Society at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 days and older
Conditions the study is for
Cardiogenic Shock
How many people
1,000 participants
Where
2 sitesFrance
Study dates
Jan 2027to Jan 2033
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 days and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Adult or pediatric patients presenting with cardiogenic shock

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
  1. 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
  1. 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%
  1. 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
  1. 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France2 sites
  • CHU Nouvel Hôpital Civil

    Strasbourg, 67000

    Hamid MERDJI, MD, 01 44 90 70 28 ext. +33, frenshock2@sfardio.fr

  • Hôpital Rangueil

    Toulouse, 31400

    Clément DELMAS, MD, 01 44 90 70 28 ext. +33, frenshock2@sfardio.fr

Other trials in France

About this study

Official title: French Observatory on the Management of Cardiogenic Shock 2 (FRENSHOCK 2)

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.

Keywords
heart disease, shock, Cardiogenic shock
Medical subject headings
Shock, Cardiogenic, Heart Diseases, Shock

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07868757
Study groupRoleWhat they receive
Patients hospitalized with cardiogenic shockConsecutive adult and pediatric patients hospitalized with cardiogenic shock of any etiology and enrolled during the index hospitalization.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (19)
  1. 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.

    Measured: Baseline

  2. Cognitive impairment assessed by the Codex test

    Measured: Within 24 hours prior to hospital discharge

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

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

  4. albumin-to-creatinine ratio

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

  5. NYHA grade

    Measured: 1 year

  6. FEVG

    Measured: 1 year

  7. Number and percentage of patients receiving home hospitalization or admitted to a rehabilitation or palliative care unit

    Measured: From index hospitalization through 5 years of follow-up

  8. 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.

    Measured: From index hospitalization through 5 years of follow-up

  9. 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.

    Measured: From index hospitalization through 5 years of follow-up

  10. Number and percentage of patients receiving a LifeWest, pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator

    Measured: From index hospitalization through 5 years of follow-up

  11. Number and percentage of patients undergoing catheter ablation for atrial fibrillation/flutter and/or ventricular tachycardia/fibrillation

    Measured: From index hospitalization through 5 years of follow-up

  12. 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.

    Measured: From index hospitalization through 5 years of follow-up

  13. 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.

    Measured: From index hospitalization through 5 years of follow-up

  14. Number and percentage of hospital discharge survivors receiving chronic dialysis

    Measured: From index hospitalization through 5 years of follow-up

  15. 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.

    Measured: 30 days, 1 year, 5 years

  16. 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.

    Measured: 1 year, 5 years

  17. All-cause and cardiovascular mortality at 30 days, 1 year and 5 years

    Measured: 30 days, 1 year and 5 years

  18. Socioeconomic deprivation assessed by FDep indices

    Socioeconomic deprivation assessed using the French Deprivation Index (FDep) derived from INSEE territorial units (municipalities and IRIS areas).

    Measured: Baseline

  19. 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).

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionJan 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07868757
Sponsor's protocol ID
2026-A01142-49
Other IDs
2026-A01142-49
Acronym
FRENSHOCK 2
Status last verified
Sep 2026
First submitted
24 Sep 2026
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiogenic Shock, run by French Cardiology Society at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clément DELMAS, MD (01 44 90 70 28 ext. +33, frenshock2@sfardio.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality during hospitalization and at 30 days (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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