Study on Istaroxime for Patients with Cardiogenic Shock Stage C

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What is this study about?

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.

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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Nemocnice AGEL Trinec-Podlesi a.s.	Konska	Czechia
Uniwersytecki Szpital Kliniczny W Opolu	Opole	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Universita Degli Studi Di Brescia	Brescia	Italy
Ixutumiax Fjn Cspcwcfx Abv Evqvtgsjbzui Mstvtbvw	Prague	Czechia
Awyfjhm Oglpdcluiko Payc Gcnlokov Xcbqv	Bergamo	Italy

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.11.2024
Italy	Not recruiting	01.11.2024
Poland	Not recruiting	01.11.2024

Trial locations

Investigated drugs:

Istaroxime

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.

Investigated diseases:

Cardiogenic shock

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 ID:

2023-507243-11-02

Protocol code:

04-CL-2201

NCT ID:

NCT05975021

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Istaroxime for Patients with Cardiogenic Shock Stage C

What is this study about?

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