Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Trial tests lower blood pressure target to reduce medication in heart attack shock patients.
Plain English Summary
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction is a Phase 4 clinical trial sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) studying Cardiogenic Shock, Myocardial Infarction. This trial tests if using a lower blood pressure target (55 mmHg vs 65 mmHg) can reduce the need for a medication called noradrenaline in patients experiencing cardiogenic shock after a heart attack. It is for adult patients who have had a heart attack (STEMI or NSTEMI) and are in cardiogenic shock, a life-threatening condition where the heart can't pump enough blood. Participation involves being randomly assigned to one of two treatment groups and closely monitoring blood pressure and organ function. Standard treatment for cardiogenic shock involves maintaining a higher blood pressure target with medications like noradrenaline. The trial aims to enroll 776 participants.
Official Summary
Rationale: Pump failure due to acute myocardial infarction (AMI) can lead to cardiogenic shock (CS): a state of low blood flow to end-organs with subsequent multi-organ failure that is associated with high mortality rated. The first line pharmacologic treatment strategy in CS is noradrenaline. This vasopressor drug is used to maintain adequate blood pressures. The assumption is that a mean arterial blood pressure (MAP) ≥ 65 mmHg will improve flow and thereby tissue perfusion of myocardium and other tissues (e.g. renal). However, there is no evidence that an increase in MAP, if achieved by noradrenaline, leads to greater end-organ blood flow and better outcomes. Objective: With this study the investigators aim to investigate the (cost-)effectiveness of reduced noradrenaline in patients with CS by using a lower MAP target of ≥ 55 mmHg, compared to ≥ 65 mmHg. The investigators hypothesize that reduced use of noradrenaline will improve overall survival and decrease renal failure requiring renal replacement therapy. Study design: Open label, randomized controlled multicenter trial Study population: Adults patients with CS due to AMI Intervention: Treatment strategy of reduced noradrenaline, by using a lower MAP target ( ≥ 55 mmHg). Main study endpoint: composite of all-cause mortality and severe renal failure leading to renal replacement therapy within 30-days after randomization.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults who have had a heart attack (STEMI or NSTEMI) and are in cardiogenic shock. Patients must have signs of low blood pressure or need medication to keep blood pressure up, along with signs of organ damage (like confusion, cold skin, low urine output, or high lactate levels) and fluid in the lungs. Patients who have had resuscitation for over 30 minutes, have a mechanical cause for shock, shock onset more than 12 hours ago, or need immediate mechanical support (like ECPR) cannot join. Women under 45 years old are also excluded. This trial is studying Cardiogenic Shock, Myocardial Infarction, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The main goal is to see if a lower blood pressure target reduces the combined risk of death or severe kidney failure requiring dialysis within 30 days. The specific primary outcome measures are: Mortality and renal failure (30-days). 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 is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because cardiogenic shock after a heart attack has a very high mortality rate, and this study aims to find a safer way to manage it by potentially reducing the dose of a critical me This research targets Cardiogenic Shock, Myocardial Infarction, where improved treatment options are needed.
Investor Insight
This trial addresses a critical unmet need in managing a high-mortality condition, potentially leading to a new standard of care and impacting the market for cardiovascular medications. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes. The large enrollment target of 776 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor about the specific blood pressure targets used in your care and the potential benefits and risks of reducing noradrenaline. Participation will involve close monitoring of your blood pressure, heart function, and organ function in an intensive care setting. Your treatment will be decided randomly, meaning you will either receive the standard higher blood pressure target or the lower target being tested. This trial is currently recruiting participants. The trial is being conducted at 1 site. 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: 776 participants
Interventions
- DRUG: Reduced noradrenaline use — Reduced noradrenaline by using a lower MAP target
Primary Outcomes
- Mortality and renal failure (30-days)
Secondary Outcomes
- Blood pressure (systolic and diastolic) (The first 24 hours)
- Heart rate (The first 24 hours)
- Enzymatic infarct size, measured by hs-Troponin T (0, 6, 12, 24, 36 and 72 hours)
- Enzymatic infarct size, measured by CK-MB (0, 6, 12, 24, 36 and 72 hours)
- Need for mechanical circulatory support (Recorded after ICU/CCU discharge, assessed up to 60 days)
Trial Locations
- Amsterdam UMC, location AMC, Amsterdam, Netherlands
Frequently Asked Questions
What is clinical trial NCT05168462?
NCT05168462 is a Phase 4 INTERVENTIONAL study titled "Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction." It is currently recruiting and is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial targets enrollment of 776 participants.
What conditions does NCT05168462 study?
This trial investigates treatments for Cardiogenic Shock, Myocardial Infarction. The primary condition under study is Cardiogenic Shock.
What treatments are being tested in NCT05168462?
The interventions being studied include: Reduced noradrenaline use (DRUG). Reduced noradrenaline by using a lower MAP target
What does Phase 4 mean for NCT05168462?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT05168462?
This trial is currently "Recruiting." It started on 2022-10-01. The estimated completion date is 2028-04-01.
Who is sponsoring NCT05168462?
NCT05168462 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05168462?
The trial aims to enroll 776 participants. The trial is currently recruiting and accepting new participants.
How is NCT05168462 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT05168462?
The primary outcome measures are: Mortality and renal failure (30-days). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05168462 being conducted?
This trial is being conducted at 1 site, including Amsterdam (Netherlands).
Where can I find official information about NCT05168462?
The official record for NCT05168462 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05168462. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05168462 testing in simple terms?
This trial tests if using a lower blood pressure target (55 mmHg vs 65 mmHg) can reduce the need for a medication called noradrenaline in patients experiencing cardiogenic shock after a heart attack. It is for adult patients who have had a heart attack (STEMI or NSTEMI) and are in cardiogenic shock, a life-threatening condition where the heart can't pump enough blood.
Why is this trial significant?
This trial matters because cardiogenic shock after a heart attack has a very high mortality rate, and this study aims to find a safer way to manage it by potentially reducing the dose of a critical me
What are the potential risks of participating in NCT05168462?
The main risks are related to the underlying severe heart condition and the potential for inadequate blood flow to organs if the blood pressure target is not met. Side effects of noradrenaline can include irregular heart rhythms, reduced blood flow to extremities, and other issues. There is a risk of kidney failure requiring dialysis, which is one of the main outcomes being measured. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05168462?
Ask your doctor about the specific blood pressure targets used in your care and the potential benefits and risks of reducing noradrenaline. Participation will involve close monitoring of your blood pressure, heart function, and organ function in an intensive care setting. Your treatment will be decided randomly, meaning you will either receive the standard higher blood pressure target or the lower target being tested. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05168462 signal from an investment perspective?
This trial addresses a critical unmet need in managing a high-mortality condition, potentially leading to a new standard of care and impacting the market for cardiovascular medications. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves being randomly assigned to one of two treatment groups and closely monitoring blood pressure and organ function. 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.
Related Conditions
More Cardiogenic Shock Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.