NCT07345559

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
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

Study Progress4%
Mar 2026Jul 2029

First Submitted

Initial submission to the registry

November 27, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2029

Last Updated

April 2, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

November 27, 2025

Last Update Submit

April 1, 2026

Conditions

Cardiogenic Shock

Keywords

Cardiogenic shockInotropesvasopressorsMean arterial pressureCentral Venous PressureOrgan dysfunctionMortality

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.

    7 days and 28 days after randomization

Secondary Outcomes (18)

  • Mortality in the intensive care unit (ICU), and in hospital

    28 days and 90 days after randomization

  • Length of stay in the ICU and in the hospital

    28 days and 90 days after randomization

  • Proportion of patients requiring cardiac mechanical circulatory support

    28 days after randomization

  • Proportion of patients requiring renal replacement therapy

    28 days after randomization

  • Proportion of patients with severe acute kidney injury (stage 2 and stage 3 according to KDIGO AKI classification)

    7 days after randomization

  • +13 more secondary outcomes

Study Arms (2)

Personalized MAP

EXPERIMENTAL
Other: Personalized MAP

Standard MAP

ACTIVE COMPARATOR
Other: Standard MAP

Interventions

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.

Personalized MAP
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.

Standard MAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged ≥18 years
  • Cardiogenic shock state, according to the consensus definition,
  • SCAI (Society for Cardiovascular Angiography and Interventions) classification ≥ C
  • Benefiting fromciary of a social security scheme

You may not qualify if:

  • Catecholamine infusion for more than 24 consecutive hours;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU d'Amiens-Picardie

Amiens, 80000, France

NOT YET RECRUITING

Hôpital Henri Mondor

Créteil, 94010, France

NOT YET RECRUITING

Hôpital Privé Jacques Cartier

Massy, 91300, France

NOT YET RECRUITING

CMC Ambroise Paré - Hartmann

Neuilly-sur-Seine, 92200, France

RECRUITING

CHU d'Orléans

Orléans, 45100, France

NOT YET RECRUITING

Hôpital Lariboisière

Paris, 75010, France

NOT YET RECRUITING

Hôpital Cochin

Paris, 75014, France

NOT YET RECRUITING

Clinique NCT + /Saint-Gatien

Saint-Cyr-sur-Loire, 37540, France

NOT YET RECRUITING

Centre Cardiologique du Nord

Saint-Denis, 93200, France

NOT YET RECRUITING

CHRU de Strasbourg

Strasbourg, 67000, France

NOT YET RECRUITING

CHU de Toulouse

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Central Study Contacts

Armand MEKONTSO DESSAP, MD

CONTACT

+ 33 1 45 17 85 06armand.dessap@aphp.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2025

First Posted

January 15, 2026

Study Start

March 26, 2026

Primary Completion (Estimated)

July 25, 2029

Study Completion (Estimated)

July 25, 2029

Last Updated

April 2, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(11)