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Study of Lower Blood Pressure Targets Using Noradrenaline in Patients with Heart Attack-Related Cardiogenic Shock

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with acute myocardial infarction (heart attack) complicated by cardiogenic shock, a serious condition where the heart cannot pump enough blood to meet the body's needs. The condition is characterized by low blood pressure, altered mental state, cold skin, decreased urine output, and build-up of fluid in the lungs.

The research examines the use of noradrenaline, a medication given through an intravenous infusion to raise blood pressure in patients with cardiogenic shock. The study aims to determine if using lower doses of noradrenaline to maintain a lower blood pressure target leads to better outcomes compared to standard treatment.

During the study, participants will be divided into two groups. One group will receive the standard blood pressure treatment, while the other group will receive treatment aimed at maintaining a lower blood pressure target with reduced noradrenaline use. The study will track the survival of patients and their kidney function over a 30-day period after treatment begins.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial evaluation
Your condition will be assessed to confirm acute myocardial infarction (heart attack) with cardiogenic shock (a serious condition where your heart cannot pump enough blood).
You will undergo an initial heart procedure called PCI (Percutaneous Coronary Intervention) to restore blood flow to your heart.
Step 2
Blood pressure monitoring
Your blood pressure will be continuously monitored through an intravenous line.
The medical team will check for signs such as mental status changes, skin temperature, urine output, and blood lactate levels to assess your organ function.
Step 3
Medication administration
You will receive norepinephrine (noradrenaline) through an intravenous infusion to help maintain your blood pressure.
The dosage will be adjusted based on your assigned treatment group and blood pressure readings.
Step 4
30-day monitoring period
Your condition will be monitored for 30 days after starting treatment.
The medical team will track your kidney function and overall health status.
The number of days you spend outside the hospital during this period will be recorded.
Step 5
Final assessment
At the end of 30 days, your overall health status will be evaluated.
Special attention will be given to your kidney function and whether you required any kidney support treatments.

Who can join the trial?

12 criteria

check
Patient must have experienced an acute myocardial infarction (heart attack), either:
- STEMI (heart attack where a major heart artery is completely blocked)
- NSTEMI (heart attack where a heart artery is partially blocked)
- Must have undergone early revascularization by PCI (a procedure to restore blood flow to the heart using a catheter)
- check
  Must have cardiogenic shock with ALL of the following conditions:
  - Either:
    
    Low blood pressure (below 90 mmHg) for more than 30 minutes, OR
    Requiring medications to keep blood pressure above 90 mmHg
    At least one sign of poor organ blood flow:
    
    Mental status changes
    Cold and clammy skin
    Low urine output (less than 30ml per hour)
    High blood lactate levels (above 2.0 mmol/L)
    Signs of fluid in the lungs
    Both men and women can participate
    Must be an adult (18 years or older)

Who cannot join the trial?

15 criteria

Age below 18 years or above 85 years
Known pregnancy or breastfeeding
Previous severe allergic reactions to medications similar to those used in the study
Active bleeding that cannot be controlled
Participation in another clinical trial within the last 30 days
Septic shock (a severe infection causing dangerously low blood pressure)
Terminal illness with life expectancy less than 30 days
Severe brain injury or stroke in the last 14 days
Unable to provide informed consent and no legally authorized representative available
Severe liver disease (advanced cirrhosis)
End-stage kidney disease requiring regular dialysis
Known severe heart valve disease
Recent major surgery within the past 72 hours
Do not resuscitate (DNR) or do not intubate (DNI) orders in place
Severe uncontrolled high blood pressure before the heart attack

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands
Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Noradrenaline (also known as norepinephrine) is a medication used to treat very low blood pressure in critically ill patients. It helps to increase blood pressure by tightening blood vessels. In this trial, researchers are studying whether using less of this medication in patients who have cardiogenic shock (a condition where the heart suddenly can't pump enough blood) after a heart attack might lead to better outcomes. This medication is typically given through an intravenous (IV) line directly into the bloodstream.

Noradrenaline Tartrate

What is already known about the treatment

Noradrenaline - A naturally occurring hormone and neurotransmitter that is also used as a medication administered intravenously in intensive care settings to treat severe low blood pressure and cardiogenic shock. This powerful vasoconstrictor works by stimulating alpha-receptors in blood vessels, causing them to narrow and thereby increasing blood pressure and improving blood flow to vital organs. In clinical practice, noradrenaline is classified as a sympathomimetic agent and is considered a first-line vasopressor for managing cardiogenic shock following acute myocardial infarction, though current research is exploring whether reduced dosing strategies might improve patient outcomes. The medication requires careful monitoring in an intensive care setting due to its potent effects on the cardiovascular system.

Investigated diseases

Acute myocardial infarction with cardiogenic shock – A severe condition where a heart attack leads to the heart's sudden inability to pump enough blood to meet the body's needs. The heart attack damages a large portion of heart muscle, causing a dramatic drop in blood pressure and reduced blood flow to vital organs. This condition develops when heart muscle damage is extensive enough that the heart cannot maintain adequate circulation. The reduced blood flow affects multiple organs, leading to their dysfunction. As the condition progresses, it creates a cycle where poor heart function and reduced organ perfusion worsen each other.