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

3 1 1

What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Gentofte Hospital	Hellerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.11.2023

Trial locations

Investigated drugs:

Colchicine

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.

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.

Trial ID:

2023-506207-26-00

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?