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Study on Early Use of Ivabradine for Children with Heart Failure Due to Dilated Cardiomyopathy

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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 the effects of a medication called Ivabradine in children who have a heart condition known as acute heart failure due to dilated cardiomyopathy. Dilated cardiomyopathy is a disease where the heart becomes enlarged and cannot pump blood effectively. The purpose of the study is to evaluate how well Ivabradine can help manage heart rate in these young patients.

Participants in the study will receive Ivabradine in the form of film-coated tablets. The study will observe the effects of the medication over a period of time, starting with 14 days of stable therapy. During this time, researchers will monitor changes in heart rate and other health indicators. The study will also include a follow-up period of four months to assess longer-term effects.

The trial aims to understand how Ivabradine affects heart rate and other related health measures, such as the levels of a heart-related protein called NT-proBNP and the function of the heart's left ventricle, which is the chamber responsible for pumping oxygen-rich blood to the body. The results will help determine the potential benefits of early administration of Ivabradine in children with this heart condition.

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

    Introduction to the study

    The study focuses on the early administration of ivabradine in children with heart failure due to dilated cardiomyopathy.

    The main goal is to evaluate the response to ivabradine on heart rate after 14 days of stable therapy.

  2. Step 2

    Eligibility confirmation

    Eligibility includes children over 6 months and under 18 years with dilated cardiomyopathy and specific heart rate and blood pressure criteria.

    The condition must include an episode of acute heart failure in the last three months.

  3. Step 3

    Medication administration

    The medication used is Ivabradine Accord 5 mg film-coated tablets.

    The route of administration is oral.

  4. Step 4

    Initial treatment phase

    The initial phase involves 14 days of stable ivabradine therapy.

    The primary endpoint is the change in heart rate from baseline after this period.

  5. Step 5

    Follow-up phase

    A follow-up period extends to 4 months to monitor heart rate and other health indicators.

    Secondary endpoints include changes in heart rate, serum NT-proBNP levels, and left ventricular function.

  6. Step 6

    Evaluation and conclusion

    The study aims to conclude by the end of 2026.

    The results will focus on the effectiveness of ivabradine in managing heart rate and improving heart function in the specified patient group.

Who can join the trial?

9 criteria

  • Patients must be older than 6 months and younger than 18 years.
  • Must have a condition called dilated cardiomyopathy, which means the heart is enlarged and doesn't pump well. This is defined by the heart being larger than normal by more than 2 standard deviations and having reduced movement.
  • The heart's ejection fraction must be less than 40%. This is a measure of how well the heart is pumping blood.
  • Must have had an episode of acute heart failure in the last three months. This can be a new occurrence or a repeat episode.
  • The systolic blood pressure must be above the 50th percentile for the patient's age and height. Systolic blood pressure is the top number in a blood pressure reading, indicating the pressure in the arteries when the heart beats.
  • The heart rate must be more than 20% above the expected normal value for the patient's age. The expected values are:
    • For ages 6-12 months: at least 105 beats per minute (bpm)
    • For ages 1-3 years: at least 95 bpm
    • For ages 3-5 years: at least 75 bpm
    • For ages 5-18 years: more than 70 bpm

Who cannot join the trial?

10 criteria

  • Patients with any other serious heart condition besides the one being studied.
  • Patients who have had a recent heart attack.
  • Patients with severe liver or kidney problems.
  • Patients who are pregnant or breastfeeding.
  • Patients who are allergic to the study medication or similar drugs.
  • Patients who are currently participating in another clinical trial.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have had a stroke in the past six months.
  • Patients with certain types of irregular heartbeats.
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Investigated drugs

Ivabradine is a medication used in this trial to help manage heart failure in children. It works by slowing down the heart rate, which can improve the heart's efficiency and reduce symptoms of heart failure. The trial aims to evaluate how well ivabradine can stabilize the heart rate after 14 days of treatment in hospitalized children.

What is already known about the treatment

Ivabradine – Ivabradine is administered orally in tablet form and is currently being studied in clinical trials for its effects on heart rate in children with acute heart failure due to dilated cardiomyopathy. It is recognized in medical literature as a heart rate-lowering medication. The main therapeutic indication for ivabradine is to reduce heart rate in patients with heart failure. At the molecular level, ivabradine works by selectively inhibiting the If current in the sinoatrial node, which is responsible for regulating heart rate. It is classified pharmacologically as a hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker.

Investigated diseases

Acute Heart Failure in Dilated Cardiomyopathy – This condition occurs when the heart suddenly becomes unable to pump blood effectively, often due to the weakening and enlargement of the heart's main pumping chamber. In dilated cardiomyopathy, the heart muscle becomes stretched and thin, leading to a decrease in its ability to contract and pump blood. As a result, blood flow to the body and lungs is reduced, causing symptoms such as shortness of breath, fatigue, and fluid retention. The progression of this disease can lead to worsening heart function and increased symptoms over time. It is considered a rare condition and requires careful management to stabilize heart function.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IITrial ID2025-520916-32-00Protocol codeEASI-ChildEstimated enrolment9 patientsSponsorOspedale Pediatrico Bambino Gesu

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