NCT05168462 Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
| NCT ID | NCT05168462 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Cardiogenic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 776 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 776 participants in total. It began in 2022-10-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria: 1. Acute myocardial infarction, STEMI or NSTEMI 2. Early revascularization by PCI 3. Cardiogenic shock, characterized by: I. a. Systolic blood pressure (SBP) ≤ 90 mmHg for \> 30 minutes, OR b. Use of drugs to maintain SBP \> 90 mmHg at randomization. II. Clinical signs of impaired organ perfusion with at least one of the following criteria: 1. Altered mental status 2. Cold, clammy skin and extremities 3. Oliguria with urine output \< 30ml/hour 4. Serum lactate \> 2.0 mmol/L III. Clinical signs of pulmonary congestion Exclusion Criteria: 1. Resuscitation \> 30 minutes 2. Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture) 3. Onset of shock \> 12 hours 4. Imminent need for mechanical circulatory support (i.e. ECPR) 5. Women \<45 years
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05168462 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiogenic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05168462 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05168462 currently recruiting?
Yes, NCT05168462 is actively recruiting participants. Contact the research team at e.j.peters@amsterdamumc.nl for enrollment information.
Where is the NCT05168462 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05168462 clinical trial?
NCT05168462 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The trial plans to enroll 776 participants.