Actively Recruiting
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2026-03-27
776
Participants Needed
1
Research Sites
287 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Acute myocardial infarction, STEMI or NSTEMI
- Early revascularization by PCI
- Cardiogenic shock defined by:
- Systolic blood pressure 64 90 mmHg for more than 30 minutes, OR use of drugs to maintain systolic blood pressure above 90 mmHg at randomization
- Clinical signs of impaired organ perfusion with at least one of the following: altered mental status, cold and clammy skin and extremities, urine output less than 30 ml/hour, serum lactate above 2.0 mmol/L
- Clinical signs of pulmonary congestion
You will not qualify if you...
- Resuscitation lasting more than 30 minutes
- Mechanical cause of cardiogenic shock (e.g., papillary muscle rupture, ventricular septal rupture)
- Onset of shock more than 12 hours before enrollment
- Imminent need for mechanical circulatory support such as extracorporeal cardiopulmonary resuscitation (ECPR)
- Women younger than 45 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ
Actively Recruiting
Research Team
E
Elma Peters
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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