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Taking people in NetherlandsPhase 4

Tests a lower blood pressure target with less noradrenaline in heart attack shock

Tests a lower blood pressure target using less noradrenaline in adults with heart attack shock.

Key facts

Who runs it
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Where
Amsterdam, NetherlandsSee the site
Trial code
Registry 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
Status
Recruiting
Phase
Phase 4
People taking part
776 people, planned
Started
1 Oct 2022
Expected to end
1 Apr 2028
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Reduced noradrenaline use
Record updated
27 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who are in cardiogenic shock (very low blood flow) caused by an acute heart attack and who had early artery-opening treatment (PCI).

Age
18 years or older
Sex
All sexes can join (women under 45 years cannot join).
Disease stage
Acute heart attack (STEMI or NSTEMI) with cardiogenic shock: systolic blood pressure 90 mmHg or lower for more than 30 minutes, or drugs needed to keep it above 90 mmHg. Signs of poor organ blood flow and of fluid in the lungs are also needed.
Earlier treatment
Early revascularization by PCI (opening the blocked heart artery) is needed.
Biomarker or test result
At least one sign of poor organ blood flow: altered mental status, cold clammy skin and limbs, urine output under 30ml/hour, or serum lactate above 2.0 mmol/L.

Main reasons for not taking part

  • Resuscitation for more than 30 minutes
  • Mechanical cause of the shock, such as papillary muscle rupture or ventricular septal rupture
  • Shock that started more than 12 hours ago
  • Imminent need for mechanical circulatory support (ECPR)
  • Women under 45 years

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Acute myocardial infarction, STEMI or NSTEMI
  • Early revascularization by PCI
  • Cardiogenic shock, characterized by:
  • a. Systolic blood pressure (SBP) ≤ 90 mmHg for > 30 minutes, OR b. Use of drugs to maintain SBP > 90 mmHg at randomization
  • Clinical signs of impaired organ perfusion with at least one of the following criteria:
  • Altered mental status
  • Cold, clammy skin and extremities
  • Oliguria with urine output < 30ml/hour
  • Serum lactate > 2.0 mmol/L
  • Clinical signs of pulmonary congestion

Who cannot take part

  • Women <45 years
  • Resuscitation > 30 minutes
  • Mechanical cause of cardiogenic shock (e.g. papillary muscle rupture, ventricular septal rupture)
  • Onset of shock > 12 hours
  • Imminent need for mechanical circulatory support (i.e. ECPR)

Where in Netherlands

  • Amsterdam UMC, location AMCAmsterdam, NetherlandsContact: Jose HenriquesTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Reduced noradrenaline (MAP ≥ 55 mmHg)Treatment being tested

    Treatment: Reduced noradrenaline use

  • Usual care (MAP ≥ 65 mmHg)No study treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests a lower blood pressure target with less noradrenaline in heart attack shockGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 March 2026