Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Istaroxime for Patients with Cardiogenic Shock Stage C

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Istaroxime on a condition known as Cardiogenic Shock. Cardiogenic shock is a serious condition where the heart suddenly can't pump enough blood to meet the body's needs, often due to severe heart failure. The trial aims to evaluate how well Istaroxime can help increase blood pressure in patients experiencing this condition. Istaroxime is administered as a powder mixed into a solution and given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The study is designed to compare the effects of Istaroxime with a placebo, which is a substance with no active medication. Participants in the trial will be randomly assigned to receive either Istaroxime or the placebo. The main goal is to see if Istaroxime can safely and effectively raise the systolic blood pressure, which is the pressure in the arteries when the heart beats, in patients with cardiogenic shock. The trial will also look at other outcomes, such as the need for additional medications to support heart function and the number of days patients are alive and out of the hospital within a month of starting the treatment.

Participants will be monitored closely throughout the study, which will last for a short period, with the main focus on the first few days after treatment begins. The trial will help determine if Istaroxime can be a beneficial treatment option for people suffering from cardiogenic shock, potentially improving their recovery and overall health outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be required to sign a consent form to confirm your willingness to participate.

    You will be admitted to the intensive care unit (ICU) within 36 hours prior to the start of the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your condition, which includes a chest x-ray or lung ultrasound to check for pulmonary congestion.

    Your blood pressure and heart function will be evaluated to ensure they meet the trial's criteria.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the trial medication, istaroxime, or a placebo.

    This process ensures that the trial results are unbiased and scientifically valid.

  4. Step 4

    Medication administration

    If assigned to the medication group, you will receive istaroxime through an intravenous infusion.

    The infusion will be administered over a specified period, and your response will be closely monitored.

  5. Step 5

    Monitoring and follow-up

    Your systolic blood pressure (SBP) will be monitored from the start of the infusion to 6 hours to assess the medication's effect.

    Additional assessments will be conducted at 24 and 48 hours to evaluate your response to the treatment.

  6. Step 6

    End of trial participation

    Your participation in the trial will conclude after the final assessments are completed.

    You will be informed about the next steps and any further follow-up that may be required.

Who can join the trial?

7 criteria

  • Signed an informed consent form, which means you agree to participate in the study after understanding all the details.
  • Have a clinical condition that matches SCAI Stage C cardiogenic shock, which is a specific type of heart problem caused by acute decompensated heart failure (ADHF).
  • Admitted to the Intensive Care Unit (ICU) within the last 36 hours and have signs of fluid in the lungs, shown by a chest x-ray or lung ultrasound, and specific blood test results (BNP ≥ 400 pg/mL or NT-proBNP ≥ 1400 pg/mL).
  • Be between 18 and 85 years old.
  • Have a history of left ventricular ejection fraction (LVEF) ≤ 40%, which means the heart's left ventricle pumps out less than 40% of the blood it contains with each beat.
  • Have ongoing low blood pressure, defined as systolic blood pressure (SBP) between 70 and 90 mmHg, along with signs of poor blood flow to the body's organs.
  • Have an echocardiogram (a heart ultrasound) during the initial hospital stay that confirms the ejection fraction is ≤ 40% and shows no other heart problems that could affect the results.

Who cannot join the trial?

2 criteria

  • Patients who have received digoxin since admission to the hospital. Digoxin is a medication used to treat certain heart conditions.
  • Patients who are on mechanical support for the heart, lungs, or kidneys. This means using machines to help these organs work.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Istaroxime is a medication being studied for its potential to help people with a specific type of heart problem called cardiogenic shock. This condition happens when the heart suddenly can't pump enough blood to meet the body's needs, often due to severe heart failure. Istaroxime is being tested to see if it can safely increase blood pressure in these patients, which is important because low blood pressure can be dangerous. The trial is focused on patients who have been hospitalized for heart failure and have low blood pressure that hasn't improved with standard treatments. The goal is to see if istaroxime can help stabilize their condition without causing harmful side effects.

What is already known about the treatment

Istaroxime – Istaroxime is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its potential use in treating cardiogenic shock, a condition where the heart suddenly can't pump enough blood to meet the body's needs. The main therapeutic indication for istaroxime is to help increase systolic blood pressure in patients experiencing this type of shock. At the molecular level, istaroxime works by enhancing the heart's ability to contract and by helping the heart muscle relax, which improves blood flow. It is classified pharmacologically as a cardiotonic agent, which means it is designed to improve the heart's function.

Investigated diseases

Cardiogenic Shock – Cardiogenic shock is a condition where the heart suddenly cannot pump enough blood to meet the body's needs. It often occurs after a severe heart attack, leading to a significant drop in blood pressure. As the heart struggles to function, organs and tissues may not receive adequate oxygen and nutrients. This can cause symptoms such as rapid breathing, severe shortness of breath, and confusion. The condition can progress quickly, leading to further complications if not addressed. It is a critical state that requires immediate medical attention to support heart function and blood circulation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507243-11-02Protocol code04-CL-2201Estimated enrolment170 patientsSponsorWindtree Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.