Prospective, Randomized, Multicenter, Controlled Trial Assessing the Personalization of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock
Trial tests personalized blood pressure targets for cardiogenic shock patients.
Plain English Summary
Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock is a Not Applicable clinical trial sponsored by CMC Ambroise Paré studying Cardiogenic Shock. This study tests if adjusting blood pressure targets based on individual patient needs improves outcomes for adults with cardiogenic shock. It is for adult patients experiencing cardiogenic shock, a severe condition where the heart can't pump enough blood. Participation involves being randomly assigned to either a standard or a personalized blood pressure management approach. Standard treatment for cardiogenic shock involves aiming for a specific blood pressure range, while this trial explores a more tailored approach. The trial aims to enroll 406 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with cardiogenic shock are eligible. Patients must have a certain severity of cardiogenic shock and be able to provide consent. Individuals who have been on high-dose medication for over 24 hours, have very low central venous pressure, or have severe chronic kidney disease may not be eligible. Patients with specific pre-existing conditions like tamponade, pulmonary embolism, or septic shock, or those already on mechanical support before enrollment, are excluded. This trial is studying Cardiogenic Shock, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures whether patients are more likely to survive, avoid needing mechanical heart support, or develop severe kidney failure within the first 28 days. The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because cardiogenic shock has a high mortality rate, and this study aims to find a better way to manage blood pressure to improve organ function and survival. This research targets Cardiogenic Shock, where improved treatment options are needed.
Investor Insight
This trial addresses a critical unmet need in a high-mortality condition, potentially leading to improved treatment guidelines and a significant impact on patient care.
Is This Trial Right for Me?
Ask your doctor about the specific blood pressure targets used in the trial and what the personalized approach means for you. Participation involves regular monitoring of your blood pressure, heart function, and organ function. You will be randomly assigned to one of two treatment groups, and your care will be managed by a specialized medical team. This trial is currently recruiting participants. The trial is being conducted at 11 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 406 participants
Interventions
- OTHER: Personalized MAP — 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.
- OTHER: Standard MAP — Patients receive blood pressure management aiming for a standard MAP target of 65-70 mmHg, according to international guidelines for cardiogenic shock management.
Primary Outcomes
- 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
- 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)
Trial Locations
- CHU d'Amiens-Picardie, Amiens, France
- Hôpital Henri Mondor, Créteil, France
- Hôpital Privé Jacques Cartier, Massy, France
- CMC Ambroise Paré - Hartmann, Neuilly-sur-Seine, France
- CHU d'Orléans, Orléans, France
- Hôpital Lariboisière, Paris, France
- Hôpital Cochin, Paris, France
- Clinique NCT + /Saint-Gatien, Saint-Cyr-sur-Loire, France
- Centre Cardiologique du Nord, Saint-Denis, France
- CHRU de Strasbourg, Strasbourg, France
- ...and 1 more locations
Frequently Asked Questions
What is clinical trial NCT07345559?
NCT07345559 is a Not Applicable INTERVENTIONAL study titled "Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock." It is currently recruiting and is sponsored by CMC Ambroise Paré. The trial targets enrollment of 406 participants.
What conditions does NCT07345559 study?
This trial investigates treatments for Cardiogenic Shock. The primary condition under study is Cardiogenic Shock.
What treatments are being tested in NCT07345559?
The interventions being studied include: Personalized MAP (OTHER), Standard MAP (OTHER). 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.
What does Not Applicable mean for NCT07345559?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07345559?
This trial is currently "Recruiting." It started on 2026-03-26. The estimated completion date is 2029-07-25.
Who is sponsoring NCT07345559?
NCT07345559 is sponsored by CMC Ambroise Paré. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07345559?
The trial aims to enroll 406 participants. The trial is currently recruiting and accepting new participants.
How is NCT07345559 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07345559?
The primary outcome measures are: 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). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07345559 being conducted?
This trial is being conducted at 11 sites, including Amiens; Créteil; Massy; Neuilly-sur-Seine and 7 more sites (France).
Where can I find official information about NCT07345559?
The official record for NCT07345559 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07345559. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07345559 testing in simple terms?
This study tests if adjusting blood pressure targets based on individual patient needs improves outcomes for adults with cardiogenic shock. It is for adult patients experiencing cardiogenic shock, a severe condition where the heart can't pump enough blood.
Why is this trial significant?
This trial matters because cardiogenic shock has a high mortality rate, and this study aims to find a better way to manage blood pressure to improve organ function and survival.
What are the potential risks of participating in NCT07345559?
Potential risks include side effects from medications used to manage blood pressure, such as norepinephrine. There is a risk of organ damage or failure if blood pressure management is not optimal. Complications related to central venous catheter insertion, such as infection or bleeding, are possible. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07345559?
Ask your doctor about the specific blood pressure targets used in the trial and what the personalized approach means for you. Participation involves regular monitoring of your blood pressure, heart function, and organ function. You will be randomly assigned to one of two treatment groups, and your care will be managed by a specialized medical team. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07345559 signal from an investment perspective?
This trial addresses a critical unmet need in a high-mortality condition, potentially leading to improved treatment guidelines and a significant impact on patient care. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to either a standard or a personalized blood pressure management approach. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.