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Study on the Effects of AZD5462 for Patients with Stable Chronic Heart Failure

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What is this trial about?

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

This clinical trial is focused on studying Chronic Heart Failure, a condition where the heart doesn't pump blood as well as it should. The study will test a new treatment called AZD5462, which is taken as a film-coated tablet. The purpose of the study is to evaluate the effect and dose response of AZD5462 after 24 weeks of treatment in participants with heart failure.

Participants in the study will be randomly assigned to receive either the AZD5462 tablet or a placebo, which looks like the real medication but does not contain the active ingredient. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not biased. The study will last for about 24 weeks, during which participants will take the medication orally.

Throughout the study, participants will have regular check-ups to monitor their heart health and overall well-being. These check-ups will include various tests to measure changes in heart function and health status. The goal is to see how AZD5462 affects heart failure symptoms and to determine the best dose for treatment. The study aims to provide valuable information that could lead to improved treatments for people living with chronic heart failure.

The research process

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

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of chronic heart failure, and stable medication use.

    Informed consent is required to participate in the study.

  2. Step 2

    Randomization and initial assessment

    Participants are randomly assigned to receive either the AZD5462 film-coated tablet or a placebo.

    Initial assessments include echocardiographic measurements and health status evaluations.

  3. Step 3

    Treatment phase

    The treatment involves taking the AZD5462 tablet orally. The dosage and frequency are determined by the study protocol.

    The treatment duration is 24 weeks.

  4. Step 4

    Follow-up assessments

    Echocardiographic measurements are taken at baseline, week 13, and week 25 to monitor changes.

    Health status is evaluated at baseline, week 3, week 5, week 13, and week 25.

    Cardiac biomarkers are assessed at baseline, week 5, week 13, and week 25.

  5. Step 5

    Completion of the study

    The primary endpoint is the change in echocardiographic measurements from baseline to week 25.

    Secondary endpoints include changes in health status, NYHA functional class, and cardiac biomarkers.

Who can join the trial?

8 criteria

  • Participant must be between 18 and 85 years old at the time of signing the consent form.
  • Participants must have a pre-existing diagnosis of **Chronic Heart Failure** with a classification of NYHA FC II to IV. This means the heart's ability to pump blood is reduced, and symptoms can range from mild to severe.
  • Participants must be on stable heart failure medications for at least 4 weeks before giving consent and during the screening period. If taking diuretics (medications that help remove excess fluid from the body), they must also be stable for at least 1 week before consent. Minor dose changes in diuretics are allowed if the doctor thinks it's necessary.
  • Participants must have a minimum **Body Mass Index (BMI)** of 18 kg/m² at screening. BMI is a measure of body fat based on height and weight.
  • Participants' **Left Ventricular Ejection Fraction (LVEF)** must be confirmed during screening. LVEF is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
  • Participants' **NT-pro-BNP** levels must be confirmed during screening. NT-pro-BNP is a substance that is released into the blood when the heart is under stress.
  • Female participants must not be pregnant or breastfeeding and must be unable to have children.
  • Participants must be capable of giving and willing to give signed informed consent, meaning they understand the study and agree to participate.

Who cannot join the trial?

5 criteria

  • Patients who have a different heart condition other than Chronic Heart Failure cannot participate. Chronic Heart Failure is a long-term condition where the heart doesn't pump blood as well as it should.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any other medical condition that might interfere with the study or make it unsafe for them to participate cannot join the study.
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Investigated drugs

AZD5462 is an investigational medication being studied for its potential effects on patients with chronic heart failure. The trial aims to understand how this medication works over a period of 24 weeks and to determine the most effective dose for treating heart failure. Participants in the study are stable patients with chronic heart failure, and the medication is being tested to see if it can improve their condition.

What is already known about the treatment

AZD5462 – This medication is administered orally and is currently being studied in clinical trials for its potential use in treating chronic heart failure. It is in the experimental phase, with ongoing research to determine its effectiveness and optimal dosage. The main therapeutic indication for AZD5462 is chronic heart failure, where it aims to improve heart function and patient outcomes. At the molecular level, AZD5462 works by modulating specific pathways involved in heart muscle contraction and relaxation, although the exact mechanism is still under investigation. It is classified pharmacologically as a cardiovascular agent, focusing on heart health and function.

Investigated diseases

Chronic Heart Failure – Chronic Heart Failure is a long-term condition where the heart is unable to pump blood effectively to meet the body's needs. This can lead to symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart's ability to function may continue to decline, causing worsening symptoms. The condition can result from various underlying issues, including coronary artery disease, high blood pressure, or previous heart attacks. As the heart struggles to maintain adequate circulation, other organs may also be affected, leading to further complications. Management focuses on improving quality of life and reducing symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510148-19-00Protocol codeD9090C00008Estimated enrolment372 patientsSponsorAstraZeneca AB

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