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Study on the Effects of Colchicine on Blood Vessel Function in Patients with Chronic Heart Failure and CHIP Mutations

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 the medication Colchicine on patients with Chronic Heart Failure who also have specific genetic changes known as CHIP mutations. Chronic heart failure is a condition where the heart is unable to pump blood effectively, leading to symptoms like fatigue and shortness of breath. CHIP mutations are changes in blood cells that can affect heart health. The purpose of the study is to understand how Colchicine impacts the function of blood vessels in these patients.

Participants in the study will receive either Colchicine or a placebo, which is a substance with no active medication. Colchicine is a medication that is often used to treat inflammation. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. The trial will last for a period of time during which the effects of the medication on blood vessel function and inflammation will be closely monitored.

The study aims to provide insights into the safety and effectiveness of Colchicine in improving heart and blood vessel health in patients with chronic heart failure and CHIP mutations. By understanding these effects, researchers hope to find better ways to manage heart failure and improve the quality of life for those affected by this condition.

The research process

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

Step 1
Joining the study
Upon joining the study, the patient must have signed an informed consent form after receiving detailed information about the trial.
Eligibility criteria include being 18 years or older, having ischemic cardiomyopathy with reduced left ventricular function (LVEF ≤ 40%), and stable heart insufficiency under constant optimal medical treatment for at least four weeks.
The patient must have a known status of CHIP mutations (DNMT3A and TET2) and, if applicable, a negative pregnancy test and use a highly effective method of contraception.
Step 2
Randomization and treatment
The trial is randomized and controlled, meaning patients are randomly assigned to receive either the active medication or a placebo.
The active medication is Colchicine, administered in the form of 0.5 mg tablets taken orally.
The placebo consists of Füllstoff DAC in hard gelatine capsules, which contains mannitol and colloidal silicon dioxide.
Step 3
Treatment duration
The treatment period involves regular administration of the assigned tablets, either Colchicine or placebo, as per the study protocol.
The exact duration of the treatment phase is determined by the study design and will be communicated to the patient during the trial.
Step 4
Monitoring and assessments
Throughout the trial, the patient's endothelial function will be assessed using FMD (flow-mediated dilation) measurements.
The study aims to evaluate the difference in these measurements in patients with and without CHIP mutations before and after treatment with Colchicine or placebo.
Additional assessments may include monitoring inflammatory biomarkers and genetic signatures related to inflammation.
Step 5
Completion of the trial
The trial is expected to conclude by March 1, 2026.
Upon completion, the data collected will be analyzed to determine the efficacy and safety of Colchicine in the specified patient population.

Who can join the trial?

7 criteria

Patients must be **18 years or older**.
Must have **ischemic cardiomyopathy**, which means a type of heart disease caused by narrowed heart arteries, with a **reduced left ventricular function** (LVEF less than or equal to 40%). The left ventricle is the heart's main pumping chamber.
Must have **stable heart insufficiency**, which means the heart is not pumping as well as it should, classified as **NYHA II-III**. This is a way to describe the severity of heart failure symptoms, where NYHA II means mild symptoms and NYHA III means moderate symptoms.
Must be on a **constant optimal medical treatment** for at least 4 weeks. This means the patient is receiving the best possible treatment for their condition.
Must have a **known status of CHIP mutations**, specifically **DNMT3A and TET2**. CHIP stands for clonal hematopoiesis of indeterminate potential, which is a condition where certain blood cells have genetic changes.
Must have **signed informed consent** after receiving detailed information about the study. This means the patient agrees to participate after understanding what the study involves.
For women of childbearing potential, a **negative pregnancy test** is required, and they must use a **highly effective method of contraception**.

Who cannot join the trial?

3 criteria

Patients who do not have chronic heart failure cannot participate. Chronic 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 includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have difficulty giving informed consent or are at higher risk of harm.

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Goethe University Frankfurt
Frankfurt, Germany

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Investigated drugs

Colchicine is a medication being studied for its effects on patients with chronic heart failure and specific genetic mutations. In this trial, researchers are looking at how colchicine might improve the function of the cells lining the blood vessels, reduce inflammation, and affect certain genetic markers related to inflammation.

Colchicine

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 patients with chronic heart failure, particularly those with reduced left ventricular function and specific genetic mutations. The main therapeutic indication being explored is its effect on endothelial function and inflammation in these patients. At the molecular level, colchicine works by disrupting microtubule formation, which in turn reduces inflammation by inhibiting the activation and migration of certain immune cells. It is classified as an anti-inflammatory medication.

Investigated diseases

Chronic Heart Failure – Chronic heart failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. Over time, this can lead to symptoms such as fatigue, shortness of breath, and fluid retention. The heart's reduced ability to function can result from damage to the heart muscle, often due to conditions like coronary artery disease or high blood pressure. As the disease progresses, the heart may become enlarged, and its walls may thicken or stiffen. This can further impair its ability to pump blood efficiently. Management of lifestyle and monitoring of symptoms are crucial in handling the progression of this condition.