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Study on the Effects of Colchicine on Arterial Stiffness in Patients with High Blood Pressure

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 individuals with hypertension, which is commonly known as high blood pressure. Hypertension is a condition where the force of the blood against the artery walls is too high, which can lead to cardiovascular diseases. The trial aims to understand how colchicine affects the stiffness of arteries, which is an important factor in managing hypertension. Participants in the study will receive either colchicine or a placebo, which looks like the real medication but does not contain the active ingredient.

The purpose of the study is to investigate whether colchicine can improve arterial health in patients with hypertension. Participants will be asked to take the medication orally in the form of tablets. The study will last for a period of six months, during which time the effects of the medication on the participants' arterial stiffness will be monitored. This will be done using a method called pulse wave velocity analysis, which measures how fast blood pressure waves move through the arteries.

Throughout the study, changes in blood pressure and other health indicators will be observed. These include systolic and diastolic blood pressure, which are the two numbers used to measure blood pressure, as well as other markers of heart health. The study will help determine if colchicine can be a beneficial treatment for people with hypertension, potentially offering a new way to manage this common condition.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline assessment and start of medication
On the first day after joining the trial, a series of measurements is performed. these include a test called pulse wave velocity that evaluates how stiff the arteries are, blood pressure measurements taken at the doctor’s office, an echocardiogram that looks at the size of the left‑ventricle of the heart, and blood tests for hs‑crp and hs‑tni (both are markers that can show inflammation or heart stress).
After the baseline measurements, participants are randomly assigned to receive either the test drug colchicine or a placebo that looks the same. the test drug is provided as a tablet that contains 0.5 mg of colchicine. the placebo contains only inactive ingredients such as lactose, potato starch and other fillers.
Step 2
Daily intake of study medication
Participants take one tablet each day by mouth. the tablet may contain either 0.5 mg of colchicine (test group) or the inactive substances (placebo group).
The medication is taken for a total period of six months. the tablets should be swallowed with water and can be taken at any time of day, but the same time each day is recommended to keep the dosing consistent.
Step 3
Final assessment after six months
At the end of the six‑month period, participants return for a second set of measurements that repeat the baseline tests: pulse wave velocity, office blood pressure, left‑ventricle mass index by echocardiography, and the blood tests for hs‑crp and hs‑tni.
The results from the final visit are compared with the baseline data to determine any changes that may be related to the use of colchicine versus the placebo.

Who can join the trial?

10 criteria

Must live in the Capital Region of Denmark.
Must be older than 18 years.
Must have been diagnosed with hypertension, which means high blood pressure.
Must be taking one or more medications to lower blood pressure.
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Must meet at least one of the following high-risk criteria:
- Diagnosed with type 2 diabetes mellitus, a condition where the body has trouble using sugar for energy.
- Taking medication to lower dyslipidemia, which means having unhealthy levels of fats in the blood.
- Taking two or more medications to lower blood pressure.
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  Female patients should either not be able to have children, meaning they are postmenopausal for at least one year or have had surgery to prevent pregnancy, or if they can have children, they must use one of the following birth control methods during the study and for 30 days after:
  - Hormonal contraception like birth control pills, implants, injections, patches, or vaginal rings.
  - An intrauterine device, which is a small device placed inside the uterus to prevent pregnancy.
  - Must have given written, informed consent, meaning they agree to participate after understanding the study, and must be able and willing to follow the study's requirements.

Who cannot join the trial?

4 criteria

Having a history of any **cardiovascular disease**. This means any disease related to the heart or blood vessels.
Having **hypertension**, which is another term for high blood pressure.
Being outside the specified age range for the study.
Being part of a vulnerable population, which refers to groups of people who might need special protection or care.

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Gentofte Hospital
Hellerup, Denmark

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Investigated drugs

Colchicine is a medication being studied for its potential effect on arterial stiffness in patients with high blood pressure. The trial aims to see if colchicine can help reduce the stiffness of arteries, which is an important factor in managing hypertension.

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 effects on cardiovascular diseases, particularly hypertension. The main therapeutic indication being explored is its ability to reduce arterial stiffness in patients with high blood pressure. At the molecular level, colchicine works by disrupting microtubule formation, which can reduce inflammation and potentially improve vascular function. It is classified as an anti-inflammatory medication.

Investigated diseases

Cardiovascular disease
This term refers to a group of disorders affecting the heart and blood vessels. It often involves narrowed or blocked blood vessels, which can lead to chest pain or other symptoms. Over time, these conditions can cause the heart to work harder, potentially leading to heart failure. The disease can progress as plaque builds up in the arteries, reducing blood flow. This can result in various complications, depending on which part of the cardiovascular system is affected. Lifestyle factors such as diet and exercise can influence the progression of the disease.
Hypertension
Also known as high blood pressure, this condition occurs when the force of the blood against the artery walls is consistently too high. It often develops over many years and can go unnoticed due to a lack of symptoms. As it progresses, it can cause damage to blood vessels and organs, particularly the heart, brain, kidneys, and eyes. The condition can lead to complications such as heart disease and stroke if not managed. Factors like stress, diet, and genetics can contribute to its development and progression. Regular monitoring is important to manage and understand its impact on overall health.