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

NCT ID: NCT05168462

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 776 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Reduced noradrenaline (MAP ≥ 55 mmHg)

Group Type: EXPERIMENTAL

Reduced noradrenaline use

Intervention Type: DRUG

Reduced noradrenaline by using a lower MAP target

Usual care (MAP ≥ 65 mmHg)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reduced noradrenaline use

Reduced noradrenaline by using a lower MAP target

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

J.P.S Henriques

Prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam UMC, location AMC

Amsterdam, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Elma Peters

Role: CONTACT

e.j.peters@amsterdamumc.nl

0205668380

Facility Contacts

Jose Henriques

Role: primary

j.p.henriques@amsterdamumc.nl

Other Identifiers

NL79416.018.21

Identifier Type: -

Identifier Source: org_study_id