Cardiogenic ShockCARDIOPAMNCT07345559
Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
A study testing Personalized MAP and Standard MAP in people with Cardiogenic Shock, run by CMC Ambroise Paré at 11 sites in France.
Trial summary
Cardiogenic shock is a life-threatening condition characterized by inadequate cardiac output, leading to organ hypoperfusion and high mortality. Maintaining mean arterial pressure (MAP) is crucial, but standard targets may be insufficient due to venous congestion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- Personalized MAP and Standard MAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 11 sitesFrance
- Study dates
- 26 Mar 2026to 25 Jul 2029
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥18 years
- Cardiogenic shock state, according to the consensus definition,
- SCAI (Society for Cardiovascular Angiography and Interventions) classification ≥ C
- Consent from the patient or close relative / trusted person or emergency inclusion procedure
- Benefiting fromciary of a social security scheme
Who cannot join
- Catecholamine infusion for more than 24 consecutive hours;
- CVP < 5 mm Hg at inclusion;
- MAP > 70 mmHg at inclusion;
- Chronic kidney disease stage G4 (defined by an eGFR between 15-29 ml/min/1.73 m²) or G5 (defined by an eGFR less than 15 ml/min/1.73 m²) according to the KDIGO CKD classification at inclusion;
- Chronic dialysis or presence of renal replacement therapy criteria at inclusion ;
- Recovered cardiopulmonary arrest within 7 days prior to inclusion;
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- Patient already on mechanical circulatory support at inclusion before enrollment (patients who receive support after inclusion will not be excluded);
- Primary diagnosis of tamponade, pulmonary embolism, or septic shock;
- Hypersensitivity to norepinephrine tartrate or to any of the following excipients: sodium chloride, hydrochloric acid or sodium hydroxide water for injectable preparations;
- Absence of central venous access;
- Known pregnancy or current breastfeeding;
- Under legal guardianship, curatorship, or judicial protection.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Not yet recruiting
CHU d'Amiens-Picardie
Amiens, 80000
Christophe BEYLS, MD
- Recruiting
Hôpital Henri Mondor
Créteil, 94010
Armand MEKONTSO DESSAP, MD
- Not yet recruiting
Hôpital Privé Jacques Cartier
Massy, 91300
Wulfran BOUGOUIN, MD
- Recruiting
CMC Ambroise Paré - Hartmann
Neuilly-sur-Seine, 92200
Guillaume GERI, MD
- Not yet recruiting
CHU d'Orléans
Orléans, 45100
Marc GORALSKI, MD
- Not yet recruiting
Hôpital Lariboisière
Paris, 75010
Bruno MÉGARBANE, MD
- Not yet recruiting
Hôpital Cochin
Paris, 75014
Alain CARIOU, MD
- Not yet recruiting
Clinique NCT + /Saint-Gatien
Saint-Cyr-sur-Loire, 37540
Aurélien SEEMANN, MD
- Not yet recruiting
Centre Cardiologique du Nord
Saint-Denis, 93200
Tristan MORICHAUBEAUCHANT, MD
- Not yet recruiting
CHRU de Strasbourg
Strasbourg, 67000
Hamid MERDJI, MD
- Not yet recruiting
CHU de Toulouse
Toulouse, 31000
Clément DELMAS, MD
About this study
Official title: Prospective, Randomized, Multicenter, Controlled Trial Assessing the Personalization of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
Cardiogenic shock is a life-threatening condition characterized by inadequate cardiac output, leading to organ hypoperfusion and high mortality. Maintaining mean arterial pressure (MAP) is crucial, but standard targets may be insufficient due to venous congestion. Central venous pressure (CVP) can help assess effective perfusion pressure. This study investigates whether a personalized MAP target adjusted by CVP improves organ function and survival compared to standard MAP management.
Read the detailed description
Cardiogenic shock is a severe and life-threatening condition. Its prognosis remains very poor with a high mortality rate (up to 50% in clinical series) despite recent therapeutic advances. Current recommendations suggest the use of inotropes and vasopressors to maintain tissue perfusion and prevent organ failure.
During cardiogenic shock, the mean arterial pressure (MAP) level is associated with survival. A post hoc analysis of a recent randomized trial found increased mortality among patients in cardiogenic shock whose average MAP was <70 mmHg during the first 36 hours after randomization, compared to patients with MAP ≥70 mmHg (58% vs. 29%, p<0.01). Another observational study found higher mortality among patients with a mean MAP <65 mmHg during the first 24 hours of shock compared to those with MAP ≥65 mmHg (57% vs. 28%, p<0.001). In this study, the incidence of renal failure was also inversely associated with MAP level. The optimal MAP target remains unknown during cardiogenic shock.
Due to the characteristic venous congestion, the effective perfusion pressure may be very low during cardiogenic shock despite MAP being within the usual target (65 mmHg). Furthermore, increased central venous pressure (CVP) is associated with higher mortality during cardiogenic shock. Considering venous congestion by measuring or estimating CVP is necessary to assess the effective perfusion pressure (MAP minus CVP) in order to protect against organ dysfunction. In this perspective, the MAP target should be increased by the value of the CVP.
The investigators hypothesize that personalizing the MAP target (to achieve an effective perfusion pressure of 65 mmHg) improves organ perfusion and survival during cardiogenic shock compared to the usual MAP target of 65 mmHg.
- Conditions
- Cardiogenic Shock
- Being tested
- Personalized MAP, Standard MAP
- Keywords
- Cardiogenic shock, Inotropes, vasopressors, Mean arterial pressure, Central Venous Pressure, Organ dysfunction, Mortality
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized MAPOther
Patients receive blood pressure management targeting a personalized MAP ranging from 65 mmHg + CVP to 75 mmHg + CVP, without exceeding 90 mmHg.CVP is measured via a central venous catheter positioned in the superior vena cava. After 48 hours, if tissue perfusion is restored, the MAP target may be reduced to 65-70 mmHg.
Standard MAPOther
Patients receive blood pressure management aiming for a standard MAP target of 65-70 mmHg, according to international guidelines for cardiogenic shock management.
| Study group | Role | What they receive |
|---|---|---|
| Personalized MAP | Experimental | Not described Receives: Other: Personalized MAP |
| Standard MAP | Active comparator | Not described Receives: Other: Standard MAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.
Measured: 7 days and 28 days after randomization
Secondary outcomes (18)
Mortality in the intensive care unit (ICU), and in hospital
Measured: 28 days and 90 days after randomization
Length of stay in the ICU and in the hospital
Measured: 28 days and 90 days after randomization
Proportion of patients requiring cardiac mechanical circulatory support
Measured: 28 days after randomization
Proportion of patients requiring renal replacement therapy
Measured: 28 days after randomization
Proportion of patients with severe acute kidney injury (stage 2 and stage 3 according to KDIGO AKI classification)
Defined as stage 2 or stage 3 according to the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury classification
Measured: 7 days after randomization
Duration of inotrope and vasopressor support
Measured: 28 days after randomization
Use of mechanical ventilation
Measured: 28 days after randomization
Number of ventilator-free days
Measured: 28 days after randomization
Evolution of the vasoactive inotropic score (VIS)
The clinical outcome is defined based on the Vasoactive Inotropic Score (VIS), according to published standard references
Measured: 5 days after randomization
Evolution of lactate levels
Measured: 5 days after randomization
Evaluation of mottling score
Measured: 5 days after randomisation
Evaluation of capillary refill time
Measured: 5 days after randomization
Evaluation of Sequential Organ Failure Assessment (SOFA) score
The clinical outcome is defined based on the Sequential Organ Failure Assessment (SOFA) score, according to published standard references
Measured: 5 days after randomization
Proportion of patients with sustained ventricular and/or supraventricular arrhythmias
Measured: 5 days after randomization
Proportion of patients with stroke, non-cerebral ischemia, new or recurrent myocardial infarction
Measured: 28 days after randomization
Proportion of patients with major bleeding, defined according to the ISTH classification
Defined according to the International Society on Thrombosis and Haemostasis (ISTH) classification.
Measured: 28 days after randomization
Net clinical benefit at D28 (survival without thrombotic event or major bleeding).
Measured: 28 days after randomization
Proportion of patients receiving new specific treatments after randomization during hospital stay
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start26 Mar 2026
- Primary completion25 Jul 2029 (estimated)
- Study completion25 Jul 2029 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345559
- Sponsor's protocol ID
- 2024/01
- Other IDs
- 2024-A00253-44
- Acronym
- CARDIOPAM
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicenter, Controlled Trial Assessing the Personalization of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT07345559
- Acronym / sponsor ID
- CARDIOPAM / 2024/01
- Conditions
- Cardiogenic Shock
- Keywords
- Cardiogenic shock, Inotropes, vasopressors, Mean arterial pressure, Central Venous Pressure, Organ dysfunction, Mortality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 26 Mar 2026 (actual)
- Primary completion
- 25 Jul 2029 (estimated)
- Study completion
- 25 Jul 2029 (estimated)
- First posted
- 15 Jan 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.
Cardiogenic shock is a life-threatening condition characterized by inadequate cardiac output, leading to organ hypoperfusion and high mortality. Maintaining mean arterial pressure (MAP) is crucial, but standard targets may be insufficient due to venous congestion. Central venous pressure (CVP) can help assess effective perfusion pressure. This study investigates whether a personalized MAP target adjusted by CVP improves organ function and survival compared to standard MAP management.
Detailed description
Cardiogenic shock is a severe and life-threatening condition. Its prognosis remains very poor with a high mortality rate (up to 50% in clinical series) despite recent therapeutic advances. Current recommendations suggest the use of inotropes and vasopressors to maintain tissue perfusion and prevent organ failure.
During cardiogenic shock, the mean arterial pressure (MAP) level is associated with survival. A post hoc analysis of a recent randomized trial found increased mortality among patients in cardiogenic shock whose average MAP was <70 mmHg during the first 36 hours after randomization, compared to patients with MAP ≥70 mmHg (58% vs. 29%, p<0.01). Another observational study found higher mortality among patients with a mean MAP <65 mmHg during the first 24 hours of shock compared to those with MAP ≥65 mmHg (57% vs. 28%, p<0.001). In this study, the incidence of renal failure was also inversely associated with MAP level. The optimal MAP target remains unknown during cardiogenic shock.
Due to the characteristic venous congestion, the effective perfusion pressure may be very low during cardiogenic shock despite MAP being within the usual target (65 mmHg). Furthermore, increased central venous pressure (CVP) is associated with higher mortality during cardiogenic shock. Considering venous congestion by measuring or estimating CVP is necessary to assess the effective perfusion pressure (MAP minus CVP) in order to protect against organ dysfunction. In this perspective, the MAP target should be increased by the value of the CVP.
The investigators hypothesize that personalizing the MAP target (to achieve an effective perfusion pressure of 65 mmHg) improves organ perfusion and survival during cardiogenic shock compared to the usual MAP target of 65 mmHg.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized MAP | Experimental | Other: Personalized MAP |
| Standard MAP | Active comparator | Other: Standard MAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥18 years
- Cardiogenic shock state, according to the consensus definition,
- SCAI (Society for Cardiovascular Angiography and Interventions) classification ≥ C
- Consent from the patient or close relative / trusted person or emergency inclusion procedure
- Benefiting fromciary of a social security scheme
Key exclusion criteria (12 listed)
- Catecholamine infusion for more than 24 consecutive hours;
- CVP < 5 mm Hg at inclusion;
- MAP > 70 mmHg at inclusion;
- Chronic kidney disease stage G4 (defined by an eGFR between 15-29 ml/min/1.73 m²) or G5 (defined by an eGFR less than 15 ml/min/1.73 m²) according to the KDIGO CKD classification at inclusion;
- Chronic dialysis or presence of renal replacement therapy criteria at inclusion ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized MAPPatients receive blood pressure management targeting a personalized MAP ranging from 65 mmHg + CVP to 75 mmHg + CVP, without exceeding 90 mmHg.CVP is measured via a central venous catheter positioned in the superior vena cava. After 48 hours, if tissue perfusion is restored, the MAP target may be reduced to 65-70 mmHg. | Other | Personalized MAP |
| Standard MAPPatients receive blood pressure management aiming for a standard MAP target of 65-70 mmHg, according to international guidelines for cardiogenic shock management. | Other | Standard MAP |
Primary outcome
The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.
Time frame: 7 days and 28 days after randomization
18 secondary outcomes
Mortality in the intensive care unit (ICU), and in hospital
Time frame: 28 days and 90 days after randomization
Length of stay in the ICU and in the hospital
Time frame: 28 days and 90 days after randomization
Proportion of patients requiring cardiac mechanical circulatory support
Time frame: 28 days after randomization
Proportion of patients requiring renal replacement therapy
Time frame: 28 days after randomization
Proportion of patients with severe acute kidney injury (stage 2 and stage 3 according to KDIGO AKI classification)
Time frame: 7 days after randomization
Duration of inotrope and vasopressor support
Time frame: 28 days after randomization
Use of mechanical ventilation
Time frame: 28 days after randomization
Number of ventilator-free days
Time frame: 28 days after randomization
Evolution of the vasoactive inotropic score (VIS)
Time frame: 5 days after randomization
Evolution of lactate levels
Time frame: 5 days after randomization
Evaluation of mottling score
Time frame: 5 days after randomisation
Evaluation of capillary refill time
Time frame: 5 days after randomization
Evaluation of Sequential Organ Failure Assessment (SOFA) score
Time frame: 5 days after randomization
Proportion of patients with sustained ventricular and/or supraventricular arrhythmias
Time frame: 5 days after randomization
Proportion of patients with stroke, non-cerebral ischemia, new or recurrent myocardial infarction
Time frame: 28 days after randomization
Proportion of patients with major bleeding, defined according to the ISTH classification
Time frame: 28 days after randomization
Net clinical benefit at D28 (survival without thrombotic event or major bleeding).
Time frame: 28 days after randomization
Proportion of patients receiving new specific treatments after randomization during hospital stay
Time frame: 28 days after randomization
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized MAP and Standard MAP in people with Cardiogenic Shock, run by CMC Ambroise Paré at 11 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?
The sponsor lists 5 inclusion and 12 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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 Armand MEKONTSO DESSAP, MD (+ 33 1 45 17 85 06, armand.dessap@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure. (time frame: 7 days and 28 days after randomization). 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 29 Sep 2026.