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Study on Colchicine and Thiamine for Patients with Heart Failure from Ischemic Heart Disease

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 two treatments, colchicine and thiamine, on patients with heart failure caused by ischemic heart disease. Heart failure is a condition where the heart is unable to pump blood effectively, and ischemic heart disease is a type of heart disease caused by narrowed heart arteries, which can lead to heart attacks. The study aims to understand how these treatments might help improve outcomes for people with this type of heart failure.

Participants in the study will receive either colchicine, thiamine, or a placebo. Colchicine is a medication commonly used to treat gout, while thiamine, also known as vitamin B1, is a vitamin that helps the body convert food into energy. The study will compare the effects of colchicine and thiamine on heart-related events, such as heart attacks or hospital visits due to heart failure, and overall heart health. The study will last for a period of time, during which participants will be monitored for any changes in their condition.

The purpose of this study is to determine if colchicine or thiamine can reduce the risk of serious heart-related events in people with heart failure due to ischemic heart disease. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for individuals with this condition in the future.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, heart disease history, and heart function.

    Participants must be 45 years or older with documented ischemic heart disease causing heart failure.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to document heart failure symptoms and heart function.

    This includes evaluating symptoms according to the New York Heart Association (NYHA) classification and measuring the heart's ejection fraction.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either colchicine, thiamine, or a placebo.

    Colchicine is administered as a 0.5 mg tablet for oral use.

    Thiamine is administered as a 300 mg gastro-resistant tablet for oral use.

    The placebo is a tablet designed to match the colchicine tablet.

  4. Step 4

    Treatment period

    The treatment period involves regular administration of the assigned medication.

    Participants are monitored for any heart-related events, such as heart failure hospitalizations or cardiovascular incidents.

  5. Step 5

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health status and any side effects.

    The study aims to observe the impact of the medications on heart failure outcomes and cardiovascular events.

  6. Step 6

    Completion of the study

    The study is expected to conclude by April 2028.

    Final assessments are conducted to evaluate the overall impact of the treatment on heart health.

Who can join the trial?

6 criteria

  • Must be **45 years old or older**.
  • Must have **ischemic heart disease** as the cause of **heart failure**. This means having a history of **coronary artery disease (CAD)** and a determination that the heart failure is due to ischemic heart disease.
  • Must have **NYHA class II-IV symptoms**. This refers to the New York Heart Association classification, which describes the severity of heart failure symptoms. Class II-IV means experiencing symptoms with mild to severe physical activity.
  • Must have a **left ventricular ejection fraction (LVEF)** of **45% or less** within one year before joining the study. LVEF is a measurement of how well the heart is pumping blood.
  • Must be receiving the best possible medical treatment for heart failure according to local clinical practice.
  • Can join the study whether they are in an outpatient setting (not hospitalized) or currently in the hospital.

Who cannot join the trial?

5 criteria

  • Patients who do not have Heart Failure cannot participate. Heart Failure is a condition where the heart doesn't pump blood as well as it should.
  • Patients who do not have ischemic heart disease cannot participate. Ischemic heart disease is a condition where the heart's blood supply is reduced, usually due to blockages in the heart's arteries.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, so gender is not an exclusion criterion.
  • Patients who are part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.
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Investigated drugs

  • Colchicine

    is a medication used in this trial to see if it can help people with heart failure caused by ischemic heart disease. The study is looking at whether colchicine can reduce the risk of serious heart problems, such as heart-related death, heart failure events, or other heart-related issues like heart attacks or strokes.

  • Thiamine

    is being tested in this trial to find out if it can help people with heart failure due to ischemic heart disease. The focus is on whether thiamine can lower the chances of heart-related death or the need for hospitalization due to heart failure.

What is already known about the treatment

  • Colchicine

    Colchicine is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in treating heart failure due to ischemic heart disease. The main therapeutic indication for colchicine in this context is to reduce cardiovascular death, heart failure events, and ischemic cardiovascular events. At the molecular level, colchicine works by inhibiting microtubule polymerization, which reduces inflammation and may help prevent heart-related complications. It is classified as an anti-inflammatory medication.

  • Thiamine

    Thiamine is typically administered orally or intravenously, depending on the clinical situation. In the context of heart failure due to ischemic heart disease, thiamine is being investigated for its potential to reduce cardiovascular death and heart failure hospitalizations. Thiamine, also known as vitamin B1, plays a crucial role in energy metabolism by acting as a coenzyme in the conversion of carbohydrates into energy, which is vital for heart function. It is classified as a vitamin supplement.

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 causes, including damage from a heart attack or high blood pressure. As the condition progresses, individuals may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and ankles. Over time, the heart's ability to function can worsen, leading to more severe symptoms and complications. The progression of heart failure can vary, with some people experiencing rapid changes, while others may have a more gradual decline. Management focuses on lifestyle changes and medications to help control symptoms and improve quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506675-96-00Protocol codePHRI.COLT-HFEstimated enrolment2 500 patientsSponsorHamilton Health Sciences Corporation

sourced from the EU Clinical Trials Register and site verification

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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.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).