Study of Colchicine Treatment to Slow Down Aortic Valve Stenosis Progression in Adult Patients with Moderate Disease

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What is this study about?

This study focuses on patients with Aortic Valve Stenosis, a heart condition where the aortic valve becomes narrow and stiff due to calcium buildup, making it harder for blood to flow from the heart to the rest of the body. The study will test whether colchicine, a medication given as tablets, can slow down the progression of this condition compared to placebo.

The purpose of the study is to determine if colchicine treatment can reduce the progression of moderate aortic valve stenosis by decreasing inflammation and calcium buildup in the heart valve. Participants in this study will receive either colchicine tablets or placebo tablets for approximately 24 months.

The study will use various imaging techniques to monitor changes in the heart valve over time, including computed tomography scans to measure calcium buildup, echocardiography (ultrasound of the heart) to assess blood flow through the valve, and positron emission tomography to evaluate valve activity. The study is designed so that neither the participants nor the researchers will know who is receiving which treatment.

1 Initial medical examination

A detailed examination will be performed to confirm moderate aortic valve stenosis (a condition where the heart’s aortic valve narrows).

The examination includes an echocardiogram (heart ultrasound) to assess valve function.

2 Baseline testing

A computed tomography scan will be performed to measure calcium buildup in the aortic valve.

A special imaging test called positron emission tomography will be done to examine valve activity.

An echocardiogram will measure the blood flow speed through the aortic valve.

3 Medication phase begins

You will receive either colchicine tablets (0.5 mg) or identical-looking placebo tablets.

The medication or placebo will be taken by mouth.

This phase continues for 24 months (2 years).

4 Final testing phase

After 24 months, the same tests from the baseline phase will be repeated:

– Another computed tomography scan to measure changes in valve calcium

– A second positron emission tomography scan to check valve activity

– A final echocardiogram to measure blood flow speed through the valve

5 Study completion

The study concludes after the final testing phase.

The total duration of participation is 24 months.

Who Can Join the Study?

Age between 18 and 64 years old
Both men and women can participate
Must have moderate aortic valve stenosis (a condition where the heart’s aortic valve narrows, making it harder for blood to flow) confirmed by an echocardiogram (heart ultrasound) performed within the last 6 months
Must be asymptomatic (not experiencing symptoms) from the aortic valve stenosis
The severity of valve narrowing will be measured according to:
- Aortic valve peak velocity (speed of blood flow through the valve)
- Aortic valve mean pressure gradient (pressure difference across the valve)
- Aortic valve area (size of valve opening)
Must not belong to any vulnerable population groups

Who Cannot Join the Study?

History of allergic reactions or intolerance to colchicine (the study medication)
Severe kidney disease (as this may affect how the medication is processed by the body)
Severe liver disease (as this may affect how the medication is processed by the body)
Current pregnancy or breastfeeding
Participation in other clinical trials within the past 30 days
Active bacterial or viral infections that require treatment
History of severe heart failure (a condition where the heart cannot pump blood effectively)
Severe blood disorders that affect blood cell counts
Use of medications that can interact with colchicine
Unable to provide informed consent or follow study procedures
History of gastrointestinal disorders that could affect medication absorption
Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
Life expectancy less than the duration of the study
History of substance abuse within the past year

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Noordwest Ziekenhuisgroep Stichting	Alkmaar	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.01.2022

Trial locations

Investigated drugs:

Colchicine

Colchicine is a medication commonly used to treat gout and other inflammatory conditions. In this trial, it is being studied for a different purpose – to see if it can help slow down the narrowing of the aortic valve in the heart. It works by reducing inflammation in the body. Colchicine is taken as an oral tablet and has been used in medicine for many years to treat various inflammatory conditions.

Investigated diseases:

Aortic Valve Calcification – A condition where calcium deposits build up on the aortic valve of the heart. These deposits gradually accumulate over time, making the valve tissue harder and stiffer. This process typically develops slowly over many years as part of aging.

Aortic Valve Stenosis – A condition where the heart’s aortic valve narrows, reducing blood flow from the heart to the body. The narrowing occurs when the valve becomes stiff and thickened. The heart must work harder to pump blood through the narrowed valve opening.

Aortic Valve Disease – A condition affecting the valve between the heart’s main pumping chamber and the body’s main artery. It occurs when the aortic valve doesn’t work properly, either not opening fully or not closing completely. The condition can develop gradually over time.

Cardiovascular Diseases – A group of disorders affecting the heart and blood vessels. These conditions affect how blood flows through the body and how the heart functions. They can involve changes in blood vessel structure, heart muscle function, or heart valve operation.

Inflammation – The body’s response to injury or irritation, characterized by redness, swelling, heat, and sometimes pain in the affected area. It is a protective response that helps the body heal and fight harmful stimuli. The process involves various immune system cells and chemical signals.

Calcification – A process where calcium builds up in body tissue, causing it to harden. This natural process can occur as part of aging or various health conditions. It can affect different parts of the body, including blood vessels and heart valves.

Trial ID:

2024-513486-39-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Colchicine Treatment to Slow Down Aortic Valve Stenosis Progression in Adult Patients with Moderate Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?