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 | Recruiting Phase 4 DMC

• 1 other identifier: NL79416.018.21
• Study Type: interventional
• Target: 776
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Noradrenaline; Blood pressure target; Cardiogenic shock; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Mortality and renal failure

  Composite of all-cause mortality and severe renal failure leading to renal replacement therapy

  30-days

Secondary Outcomes (10)

• Blood pressure (systolic and diastolic)

  The first 24 hours

• Heart rate

  The first 24 hours

• Enzymatic infarct size, measured by hs-Troponin T

  0, 6, 12, 24, 36 and 72 hours

• Enzymatic infarct size, measured by CK-MB

  0, 6, 12, 24, 36 and 72 hours

• Need for mechanical circulatory support

  Recorded after ICU/CCU discharge, assessed up to 60 days

Study Arms (2)

Reduced noradrenaline (MAP ≥ 55 mmHg)

EXPERIMENTAL

Drug: Reduced noradrenaline use

Usual care (MAP ≥ 65 mmHg)

NO INTERVENTION

Interventions

Reduced noradrenaline use DRUG

Reduced noradrenaline by using a lower MAP target

Reduced noradrenaline (MAP ≥ 55 mmHg)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute myocardial infarction, STEMI or NSTEMI
• Early revascularization by PCI
• 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:
• Altered mental status
• Cold, clammy skin and extremities
• Oliguria with urine output \< 30ml/hour
• Serum lactate \> 2.0 mmol/L
• III. Clinical signs of pulmonary congestion

You may not qualify if:

• 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)
• Women \<45 years

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic; Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Central Study Contacts

Elma Peters

CONTACT

0205668380; e.j.peters@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: November 8, 2021
• First Posted: December 23, 2021
• Study Start: October 1, 2022
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

NL (1)