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Study on Colchicine for Patients with Acute Heart Failure

Verified siteRegistered drugNo placebo
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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 colchicine in patients who have a condition known as acute decompensated heart failure. Heart failure is a condition where the heart is unable to pump blood effectively, and when it becomes acutely decompensated, it means the symptoms have suddenly worsened, requiring immediate medical attention. The medication being tested, colchicine, is administered in the form of tablets.

The purpose of this study is to determine if taking colchicine can help improve the condition of patients with acute decompensated heart failure. Specifically, the study aims to see if colchicine can reduce levels of a substance in the blood called NT-proBNP, which is a marker used to assess heart health and stability. Patients participating in the study will receive either colchicine or a placebo, and their progress will be monitored over a period of eight weeks following their discharge from the hospital.

Throughout the study, researchers will observe various outcomes, such as changes in NT-proBNP levels, improvements in the patients' overall stability, and any effects on the mortality rate and the total number of days spent in the hospital. This information will help determine the potential benefits of colchicine for patients with this type of 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, you will be asked to provide written consent, confirming your willingness to participate.

    Eligibility is based on specific criteria, including an unscheduled visit for heart failure symptoms requiring treatment, evidence of congestion, and certain blood test results.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking your symptoms, reviewing your medical history, and performing necessary tests.

    A blood test will be conducted to measure the concentration of a specific marker related to heart failure.

  3. Step 3

    Medication administration

    You will be randomly assigned to receive either the study medication, colchicine, or a placebo. A placebo is a substance with no active medication.

    The medication is in the form of a tablet and is taken orally.

    The dosage is 0.5 mg of colchicine, to be taken as directed by the study team.

  4. Step 4

    Follow-up period

    The follow-up period lasts for 8 weeks after hospital discharge.

    During this time, you will have regular check-ups to monitor your health and the effects of the medication.

    Blood tests will be conducted to measure changes in the specific marker related to heart failure.

  5. Step 5

    Final assessment

    At the end of the 8-week period, a final assessment will be conducted.

    This includes a review of your symptoms, any changes in your condition, and the results of your blood tests.

Who can join the trial?

5 criteria

  • Unplanned visit to the hospital for symptoms or signs of heart failure that need treatment with intravenous diuretics (at least 40 mg of intravenous furosemide). Diuretics are medicines that help remove excess fluid from the body.
  • Clinical evidence of congestion, which means there is too much fluid in the body, shown by symptoms, signs, or X-ray results.
  • NT-proBNP concentration greater than 900 pg/ml at the screening visit. NT-proBNP is a substance in the blood that can indicate heart stress.
  • Age over 18 years.
  • Patients who have given their informed consent in writing, meaning they understand the study and agree to participate.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing acute decompensated heart failure cannot participate. This means the study is only for those who have a sudden worsening of heart failure symptoms.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care are not included.
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Investigated drugs

Colchicine is a medication that is being studied to see if it can help people with heart failure. Heart failure is a condition where the heart doesn't pump blood as well as it should. In this trial, researchers are looking at whether taking colchicine can help make the heart more stable after a person has been in the hospital for heart problems. They are checking if colchicine can lower certain markers in the blood that show how well the heart is doing.

What is already known about the treatment

Colchicine – Colchicine is administered orally in the form of a tablet. It is currently being studied in clinical trials for its potential benefits in treating acute decompensated heart failure. The main therapeutic indication being explored is its ability to reduce levels of NT-proBNP, a biomarker associated with heart failure, which may indicate improved clinical stability and reduced risk after hospital discharge. At the molecular level, colchicine works by disrupting the formation of microtubules, which are part of the cell's structure, thereby reducing inflammation. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Acute decompensated heart failure – This condition occurs when the heart suddenly becomes unable to pump blood effectively, leading to a rapid buildup of fluid in the lungs and other parts of the body. It often results from a worsening of chronic heart failure, where the heart's ability to function has been gradually declining. Symptoms typically include severe shortness of breath, swelling in the legs and abdomen, and fatigue. The condition can develop quickly, often requiring urgent medical attention. It is characterized by an acute onset of symptoms, which can vary in severity. The progression involves a cycle of worsening heart function and fluid retention, which can lead to further complications if not managed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504165-23-00Protocol codeIMIB-CO-2020-01Estimated enrolment302 patientsSponsorFundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

sourced from the EU Clinical Trials Register and site verification

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