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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 776 (estimated)
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock
• Myocardial Infarction

Interventions

Type	Name	Description
DRUG	Reduced noradrenaline use	Reduced noradrenaline by using a lower MAP target

Timeline

• Start date: 2022-10-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2021-12-23
• Last updated: 2026-03-27

Locations

1 site across 1 country: Netherlands