Cardiogenic ShockPhase 4NORSHOCKNCT05168462
Clinical Outcome and Cost-effectiveness of Reduced Noradrenaline by Using a Lower Blood Pressure Target in Patients With Cardiogenic Shock From Acute Myocardial Infarction
A Phase 4 study testing Reduced noradrenaline use in people with Cardiogenic Shock and Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Myocardial Infarction
- What is being tested?
- Reduced noradrenaline use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2022to 1 Apr 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Cold, clammy skin and extremities
- Oliguria with urine output < 30ml/hour
- Serum lactate > 2.0 mmol/L
- Clinical signs of pulmonary congestion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC, location AMC
Amsterdam, 1105AZ
Jose Henriques, j.p.henriques@amsterdamumc.nl
About this study
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.
Read more
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
- Being tested
- Reduced noradrenaline use
- Keywords
- Noradrenaline, Blood pressure target, Cardiogenic shock, Myocardial infarction
- Medical subject headings
- Shock, Cardiogenic, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced noradrenaline useDrug
Reduced noradrenaline by using a lower MAP target
| Study group | Role | What they receive |
|---|---|---|
| Reduced noradrenaline (MAP ≥ 55 mmHg) | Experimental | Not described Receives: Drug: Reduced noradrenaline use |
| Usual care (MAP ≥ 65 mmHg) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality and renal failure
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
Measured: 30-days
Secondary outcomes (10)
Blood pressure (systolic and diastolic)
Blood pressure measured hourly during the first 24 hours of ICU/CCU admission
Measured: The first 24 hours
Heart rate
Heart rate, measured hourly during the first 24 hours of ICU/CCU admission
Measured: The first 24 hours
Enzymatic infarct size, measured by hs-Troponin T
Size of myocardial infarction, measured by hs-Troponin T
Measured: 0, 6, 12, 24, 36 and 72 hours
Enzymatic infarct size, measured by CK-MB
Size of myocardial infarction, measured by CK-MB
Measured: 0, 6, 12, 24, 36 and 72 hours
Need for mechanical circulatory support
Type of mechanical circulatory support device
Measured: Recorded after ICU/CCU discharge, assessed up to 60 days
Duration of mechanical ventilation
Duration of mechanical ventilation, expressed in days
Measured: Recorded after ICU/CCU discharge, assessed up to 60 days
Need for vasopressors / inotropes
The type of vasopressors / inotropes that were administrered
Measured: Recorded after ICU/CCU discharge, assessed up to 60 days
Ejection fraction, percent
As measured by echocardiography and/or MRI
Measured: 72 hours and 1 year
Renal function
Renal function, measured by serum creatinin
Measured: 1 year
Cost-effectiveness
Cost per patients alive without severe renal failure and costs per QALY (quality-adjusted life year)
Measured: 1-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start1 Oct 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 776 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.P.S Henriques, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168462
- Sponsor's protocol ID
- NL79416.018.21
- Acronym
- NORSHOCK
- Status last verified
- Mar 2026
- First submitted
- 8 Nov 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05168462
- Acronym / sponsor ID
- NORSHOCK / NL79416.018.21
- Conditions
- Cardiogenic Shock, Myocardial Infarction
- Keywords
- Noradrenaline, Blood pressure target, Cardiogenic shock, Myocardial infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced noradrenaline (MAP ≥ 55 mmHg) | Experimental | Drug: Reduced noradrenaline use |
| Usual care (MAP ≥ 65 mmHg) | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced noradrenaline useReduced noradrenaline by using a lower MAP target | Drug | Reduced noradrenaline (MAP ≥ 55 mmHg) |
Primary outcome
Mortality and renal failure
Time frame: 30-days
Composite of all-cause mortality and severe renal failure leading to renal replacement therapy
10 secondary outcomes
Blood pressure (systolic and diastolic)
Time frame: The first 24 hours
Heart rate
Time frame: The first 24 hours
Enzymatic infarct size, measured by hs-Troponin T
Time frame: 0, 6, 12, 24, 36 and 72 hours
Enzymatic infarct size, measured by CK-MB
Time frame: 0, 6, 12, 24, 36 and 72 hours
Need for mechanical circulatory support
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Duration of mechanical ventilation
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Need for vasopressors / inotropes
Time frame: Recorded after ICU/CCU discharge, assessed up to 60 days
Ejection fraction, percent
Time frame: 72 hours and 1 year
Renal function
Time frame: 1 year
Cost-effectiveness
Time frame: 1-year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reduced noradrenaline use in people with Cardiogenic Shock and Myocardial Infarction, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elma Peters (0205668380, e.j.peters@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality and renal failure (time frame: 30-days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.