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.
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:
- 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
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:
- 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%
- 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
- 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
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.
- Conditions
- Cardiogenic Shock
- 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 group | Role | What they receive |
|---|---|---|
| Patients hospitalized with cardiogenic shock | Consecutive 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.
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)
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
Cognitive impairment assessed by the Codex test
Measured: Within 24 hours prior to hospital discharge
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
albumin-to-creatinine ratio
Measured: on admission, Within 24 hours prior to hospital discharge, and at 1 year
NYHA grade
Measured: 1 year
FEVG
Measured: 1 year
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
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
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
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
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
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
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
Number and percentage of hospital discharge survivors receiving chronic dialysis
Measured: 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.
Measured: 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.
Measured: 1 year, 5 years
All-cause and cardiovascular mortality at 30 days, 1 year and 5 years
Measured: 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).
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionJan 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clément DELMAS, MD, Principal investigator, Hôpital Rangueil
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Observatory on the Management of Cardiogenic Shock 2 (FRENSHOCK 2)
- ClinicalTrials.gov ID
- NCT07868757
- Acronym / sponsor ID
- FRENSHOCK 2 / 2026-A01142-49
- Conditions
- Cardiogenic Shock
- Keywords
- heart disease, shock, Cardiogenic shock
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Jan 2033 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalized with cardiogenic shock | – | –Consecutive adult and pediatric patients hospitalized with cardiogenic shock of any etiology and enrolled during the index hospitalization. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult or pediatric patients presenting with cardiogenic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality during hospitalization and at 30 days
Time frame: 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.
19 secondary outcomes
Use of in-hospital organ support therapies
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
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients undergoing transthoracic echocardiography and frequency of examinations
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
Time frame: From index hospitalization through 5 years of follow-up
Number and percentage of patients receiving chronic hemodialysis and type of hemodialysis
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
Time frame: 30 days, 1 year, 5 years
Number and percentage of hospital discharge survivors rehospitalized for heart failure
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
Time frame: Baseline
Socioeconomic deprivation assessed by F-EDI indices
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clément DELMAS, MD principal investigator
Hôpital Rangueil
2 sites in 1 country: see every site and its status.
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.