NCT05168462RecruitingPhase 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
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 776 (estimated)
- First submitted
- 8 Nov 2021
- Start date
- 1 Oct 2022
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Coronary artery disease
- NCT number
- NCT05168462
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 776
- From 1 Oct 2022 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Women \<45 years
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC, location AMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.