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Study on AP-01 for Patients with Acute Heart Failure (NYHA Class III or Higher)

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What is this study about?

This clinical trial is focused on studying Acute Heart Failure, a condition where the heart suddenly becomes unable to pump enough blood to meet the body’s needs. The study will test a treatment called AP-01, which is given through an intravenous (IV) method, meaning it is administered directly into the bloodstream. The purpose of the study is to explore how this treatment affects the heart’s metabolism, specifically looking at changes in certain substances in the blood that are related to heart function.

Participants in the study will receive either the AP-01 treatment or a placebo, which is a substance that looks like the treatment but does not contain the active ingredient. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The study will last for a period of time during which participants will be monitored for changes in their heart condition and overall health.

The main focus will be on measuring the reduction of a substance called lactate in the blood shortly after the first dose and another substance called NT-proBNP after 72 hours. These substances are indicators of heart stress and function. Additionally, the study will assess improvements in symptoms and overall heart health through tests like echocardiography, which uses sound waves to create images of the heart, and questionnaires about the participants’ quality of life. The study aims to provide valuable information on the effectiveness of AP-01 as an additional treatment for those experiencing acute heart failure.

1 joining the study

Upon joining the study, the patient must provide written informed consent. This is a formal agreement to participate, acknowledging understanding of the study’s procedures and potential risks.

Eligibility is confirmed based on specific criteria, including age over 18, recent hospitalization for acute heart failure, and certain medical test results.

2 initial assessment

An initial clinical assessment is conducted to evaluate the patient’s condition. This includes measuring blood pressure and performing echocardiography to assess heart function.

The study drug administration must begin within 12 hours after this assessment.

3 medication administration

The patient receives the study medication, G-Strophanthin, or a placebo intravenously. The placebo is a solution that looks identical to the medication but does not contain the active ingredient.

The primary goal is to observe the reduction of lactate levels within 90 minutes after the first dose and NT-proBNP levels after 72 hours.

4 monitoring and follow-up

The patient’s condition is monitored through regular assessments, including echocardiography and questionnaires to evaluate symptoms and quality of life.

These assessments occur at multiple visits, comparing initial results with those at later stages to track improvement.

5 completion of the study

The study concludes with a final evaluation of the patient’s health status, focusing on symptomatic and clinical improvements.

The duration of hospital stay, mortality, and rate of re-hospitalization are also assessed to determine the overall effectiveness of the treatment.

Who Can Join the Study?

  • Provide written informed consent, which means you agree to participate in the study after understanding all the details.
  • Be a male or female aged over 18 years.
  • Have an unplanned hospital stay or emergency visit due to Acute Heart Failure (AHF). This includes:
    • Experiencing dyspnoea, which means difficulty breathing, while sitting up, and it has worsened in the past week.
    • Having signs of heart failure on a chest X-ray or a chest CT scan.
    • Having a Brain Natriuretic Peptide (BNP) level greater than 500 pg/mL or NT-proBNP level greater than 2000 pg/mL. These are blood tests that help diagnose heart failure.
  • Have a serum lactate level of 18.0 mg/dl or higher. This is a blood test that measures lactic acid in your body.
  • Have an Ejection Fraction (EF) of less than 40% as shown by an echocardiogram. This measures how well your heart is pumping blood.
  • Be able to start taking the study medication within 12 hours after your first medical check-up.
  • Have a systolic blood pressure between 90 mmHg and 165 mmHg during your first medical check-up. Systolic blood pressure is the top number in a blood pressure reading.

Who Cannot Join the Study?

  • Patients who are not experiencing Acute Heart Failure. This means the study is only for those who have a sudden and severe worsening of heart function.
  • Patients who are not within the specified age range. The study is for certain age groups, so if you are too young or too old, you may not be eligible.
  • Patients who are part of a vulnerable population. This could include people who are unable to give consent or have certain health conditions that make participation risky.
  • Patients who do not meet other specific health criteria set by the study. These criteria are designed to ensure the safety and effectiveness of the study for participants.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Ggthpielmznixtnicuuugedp Hsmbgqhaut gtgsx Berlin Germany

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

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
15.01.2024

Trial locations

AP-01 is an investigational medication being studied as an additional treatment for acute heart failure. It is administered intravenously and is being tested to see if it can help improve heart function by reducing certain markers in the blood, such as lactate and NT-proBNP, which are associated with heart failure.

Acute Heart Failure – Acute heart failure is a sudden onset condition where the heart is unable to pump blood effectively, leading to a rapid buildup of fluid in the lungs and other parts of the body. This can cause symptoms such as shortness of breath, fatigue, and swelling in the legs and abdomen. The condition often develops quickly, sometimes within hours or days, and requires immediate medical attention. It can be triggered by various factors, including heart attacks, high blood pressure, or severe infections. As the heart struggles to meet the body’s demands, organs may not receive enough oxygen-rich blood, leading to further complications. The progression of acute heart failure can vary, but it typically involves worsening symptoms if not addressed promptly.

Trial ID:
2023-507573-17-01
Protocol code:
AP01-201
Trial Phase:
Therapeutic exploratory (Phase II)

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