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Study on the Effects of Digoxin and Activated Charcoal in Treating Heart Failure in Patients Receiving Standard Care

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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 the medication Digoxin in treating patients with Heart Failure. Heart failure is a condition where the heart is unable to pump blood effectively, leading to symptoms like shortness of breath and fatigue. The study aims to assess how well Digoxin works when combined with modern heart failure treatments, which typically include medications like ARNi, ACE inhibitors, beta-blockers, SGLT2 inhibitors, and MRAs.

Participants in the study will receive either Digoxin or a placebo, and their progress will be monitored over a period of 24 weeks. During this time, researchers will evaluate the participants' heart function and overall physical capacity. This will involve tests such as measuring peak oxygen consumption and using echocardiography, which is an ultrasound of the heart, to assess how well the heart is working.

The study will also look at other health outcomes, such as the occurrence of hospitalizations, changes in certain blood markers, and overall quality of life. By the end of the study, the researchers hope to better understand the role of Digoxin in managing heart failure and improving patients' health and well-being.

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 having chronic heart failure with reduced ejection fraction and being symptomatic.

    Informed consent is required, and the ability to comply with study procedures is assessed.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes tests to measure heart function and overall health status.

  3. Step 3

    Medication administration

    The study involves the administration of Digoxin in combination with standard heart failure treatments.

    Participants receive Lanoxin MD 0.125 mg tablets orally as part of their treatment regimen.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment. This includes measuring peak oxygen consumption and cardiac function at 24 weeks.

    Participants are monitored for any changes in health status, including hospitalizations and heart-related events.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to evaluate the overall impact of the treatment on heart function and quality of life.

    This includes a comprehensive review of all collected data and measurements.

Who can join the trial?

6 criteria

  • Have chronic heart failure with a reduced ejection fraction (LVEF ≤ 45%). This means the heart is not pumping as well as it should.
  • Have been on the highest dose you can handle of certain heart medications for at least 6 months. These medications include ARNi or ACEi, beta-blockers, SGLT2 inhibitors, and MRA, unless you cannot take them for some reason.
  • Have symptomatic heart failure with at least New York Heart Association (NYHA) class II. This means you have symptoms like shortness of breath or fatigue during normal activities.
  • Be at least 18 years old.
  • Be able to give informed consent, which means you understand the study and agree to participate.
  • Be willing to follow the study procedures.

Who cannot join the trial?

3 criteria

  • Patients who are not diagnosed with Heart Failure cannot participate. Heart Failure is a condition where the heart doesn't pump blood as well as it should.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Digoxin is a medication used in this clinical trial to evaluate its effectiveness in improving heart function and the ability to perform daily activities in patients with heart failure. It is being tested in combination with the standard treatments currently used for heart failure.

What is already known about the treatment

Digoxin – Digoxin is administered orally in tablet form or intravenously in a hospital setting. It is currently used in the treatment of heart failure and is well-documented in medical literature. The main therapeutic indication for Digoxin is to improve heart function and manage symptoms in patients with heart failure. At the molecular level, Digoxin works by inhibiting the sodium-potassium ATPase enzyme, which increases calcium concentration in heart cells, leading to stronger heart contractions. It is classified as a cardiac glycoside.

Investigated diseases

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. It can result from various underlying heart conditions that weaken or damage the heart muscle. As the disease progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. The heart may become enlarged, and its pumping ability can further decline over time. This condition often leads to fluid buildup in the lungs and other parts of the body. Heart failure can affect both the left and right sides of the heart, or sometimes both simultaneously.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513448-26-00Protocol codeDIG-Mod HFEstimated enrolment50 patientsSponsorUnidade Local De Saude De Sao Jose E.P.E.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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