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Clinical Trials in the Netherlands / NCT05168462
Recruiting Phase 4

Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction

NCT05168462 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Phase
Phase 4
Started
2022-10-01
Last updated
2026-03-27

Condition(s) studied

Cardiogenic ShockMyocardial Infarction

Investigational drug(s) / intervention(s)

Reduced noradrenaline use

Reduced noradrenaline use: Reduced noradrenaline by using a lower MAP target

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Mortality and renal failure — 30-days
    Composite of all-cause mortality and severe renal failure leading to renal replacement therapy

Trial sites (1)

FacilityCityRegionStatus
Amsterdam UMC, location AMC Amsterdam Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05168462 on ClinicalTrials.gov ↗ ← All trials in the Netherlands