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Study on the Effects of Colchicine for Patients with Heart Failure with Preserved Ejection Fraction (HFpEF)

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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 on a condition known as Heart Failure with Preserved Ejection Fraction (HFpEF). HFpEF is a type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats. The study will compare the effects of Colchicine with a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to investigate how Colchicine affects the health status of people with HFpEF. Participants will take the medication or placebo orally in the form of tablets. The study will last for a period of up to six months. During this time, participants will be monitored to see how their heart failure symptoms respond to the treatment. The main tool used to assess changes in health status will be the Kansas City Cardiomyopathy Questionnaire, which is a survey that helps measure the impact of heart failure on daily life.

Throughout the study, researchers will look at various outcomes, including any improvements in heart failure symptoms and overall health status. The goal is to determine if Colchicine can provide a meaningful benefit to people living with HFpEF compared to those taking the placebo. This research could potentially lead to better treatment options for individuals 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.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, heart function, and symptoms of heart failure.
Written consent is required to participate, ensuring understanding and agreement to comply with the study requirements.
Step 2
Initial assessment
An initial assessment is conducted to evaluate heart function and symptoms using echocardiography and other diagnostic tools.
This assessment helps establish a baseline for future comparisons.
Step 3
Medication administration
Participants receive either Colrefuz (containing colchicine) or a placebo, both in tablet form.
The medication is taken orally, with the dosage and frequency determined by the study protocol.
Step 4
Ongoing monitoring
Regular monitoring of heart health and symptoms is conducted throughout the study.
Participants complete the Kansas City Cardiomyopathy Questionnaire to assess health status related to heart failure.
Step 5
Final evaluation
At the end of the study, a final evaluation is performed to assess the effects of the medication on heart health.
The results are compared to the initial assessment to determine any changes in health status.

Who can join the trial?

8 criteria

Must be **40 years or older**.
Have a **Left Ventricular Ejection Fraction (LVEF)** of **45% or higher**. This is a measure of how well the heart pumps blood.
Have had **symptoms of heart failure** for at least **30 days** before the screening visit and currently have symptoms of heart failure. These symptoms are classified as **NYHA functional class II-IV**, which means moderate to severe symptoms.
Show **evidence of heart structure or function problems** that suggest **LV diastolic dysfunction** or **raised LV filling pressures**. This can include **left atrial enlargement** or **left ventricular hypertrophy**, as seen in an echocardiogram.
Have a **pro-BNP level** of **125 pg/ml or higher** if in normal heart rhythm, or **300 pg/ml or higher** if in **atrial fibrillation**. Pro-BNP is a blood test that helps measure heart stress.
Have a **Body Mass Index (BMI)** of **less than 40 kg/m²**. BMI is a measure of body fat based on height and weight.
Female participants should either be **not able to have children** (postmenopausal for at least 1 year or surgically sterile) or, if they can have children, they must use a reliable **method of birth control** during the study and for 30 days after it ends. This can include hormonal methods or an intrauterine device.
Must have given **written, informed consent** and be able and willing to follow the study's requirements.

Who cannot join the trial?

4 criteria

Patients who have a different type of heart failure than the one being studied.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria required for the study.

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Verified sites

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Gentofte Hospital
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Hellerup, Denmark

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Investigated drugs

Colchicine is a medication being studied for its potential effects on heart failure. In this trial, researchers are examining how colchicine might improve the health status of patients with heart failure. The goal is to see if colchicine can positively impact the symptoms and quality of life for these patients, as measured by a specific questionnaire designed to assess heart failure.

Colchicine

What is already known about the treatment

Colchicine – Colchicine is administered orally in tablet form. It is currently being studied for its potential benefits in treating heart failure with preserved ejection fraction (HFpEF). The main therapeutic indication under investigation is its effect on heart failure-related health status. At the molecular level, colchicine works by inhibiting microtubule polymerization, which reduces inflammation and may improve heart function. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Heart Failure with Preserved Ejection Fraction (HFpEF) – This condition is a type of heart failure where the heart's lower chambers are unable to fill properly with blood, despite the heart muscle contracting normally. It often results in symptoms such as shortness of breath, fatigue, and fluid retention. The heart's pumping ability remains relatively normal, but the heart muscle is stiff and less able to relax between beats. Over time, this can lead to increased pressure in the heart and lungs, causing further symptoms. HFpEF is commonly associated with aging and conditions like high blood pressure and diabetes. The progression of the disease can vary, with symptoms potentially worsening over time.