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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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)
  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General Hospital Asklepeion Voula Athens Greece
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Medisch Spectrum Twente Enschede The Netherlands
Elisabeth-Tweesteden Ziekenhuis Tilburg The Netherlands
Lund University Hospital Lund Sweden
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Universitaetsklinikum Mannheim GmbH Mannheim Germany
CHC MontLegia Liege Belgium
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Medical Center Ljubljana Ljubljana Slovenia
Rigshospitalet Copenhagen Denmark
Vrije Universiteit Brussel Jette Belgium
Lgovi Uokwamxjkvrc Menjltk Ckrlvsg (yeqva Leiden The Netherlands
Rtjgkcugt Zdvlqkuzin Sdzaydwhl Arnhem The Netherlands
Uitrichodwhf Myxgvpt Csocbjh Gfglfpdfw Groningen The Netherlands
Uyoqqkphhu Hljzgzecz Lmfmxk Leuven Belgium
Cpw dz Cqndjtbob Hgqijhl Cwsku Mepxe Crxop Charleroi Belgium
Aspmdbkdm Unj Amsterdam The Netherlands
Hsqli Bxesuz Hg Bergen Norway
Unozwqwqwrchuuhzmcwiv Dvkkznmfxjk Ags Duesseldorf Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
16.01.2024
Czechia Czechia
Recruiting
16.01.2024
Denmark Denmark
Recruiting
16.01.2024
Germany Germany
Recruiting
16.01.2024
Greece Greece
Recruiting
16.01.2024
Norway Norway
Recruiting
16.01.2024
Slovenia Slovenia
Recruiting
16.01.2024
Sweden Sweden
Recruiting
16.01.2024
The Netherlands The Netherlands
Recruiting
16.01.2024

Trial locations

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.

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.

Trial ID:
2024-510892-40-00
Protocol code:
NL79416.018.21
Trial Phase:
Therapeutic confirmatory (Phase III)

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