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Study of Allopurinol to Reduce Cardiovascular Events in High-Risk Patients with Heart Disease and Long-COVID Syndrome

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on people with high cardiovascular risk and very high cardiovascular risk, including those who have experienced long-COVID syndrome. The research examines conditions such as hyperuricemia (elevated blood uric acid levels), hypertension (high blood pressure), ischemic stroke, heart failure, peripheral arterial disease, atrial fibrillation (irregular heartbeat), and diabetes mellitus.

The study tests whether allopurinol, a medication that lowers uric acid levels in the blood, can help reduce the risk of cardiovascular events. Some participants will receive allopurinol tablets, while others will receive a placebo. The treatment will continue for approximately 5 years, during which participants will have regular check-ups to monitor their health status.

The main focus is to determine if allopurinol can prevent serious cardiovascular events such as heart problems, strokes, or the need for heart-related procedures. The study will also track other health changes, including heart function, blood vessel health, and the presence of long-COVID symptoms. Regular blood tests and heart examinations will be performed to monitor participants' health throughout the study period.

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
Initial visit and medication start
You will receive either allopurinol tablets or a placebo (inactive tablet). Neither you nor your doctor will know which one you are taking.
The study medication needs to be taken orally every day according to the prescribed schedule.
Your blood uric acid level will be checked during this visit.
Step 2
Regular health monitoring
Your health will be monitored through various tests including:
- Heart examinations (echocardiogram - ultrasound of the heart)
- Blood vessel examinations (ultrasound of neck arteries and abdominal aorta)
- Blood tests to check kidney function, blood sugar levels, and liver function
- Blood pressure measurements
- Heart rhythm checks (electrocardiogram)
Step 3
Long-term follow-up
The study will continue until May 30, 2028
Regular check-ups will monitor for any heart or blood vessel related events
Your doctor will track any COVID-19 related symptoms if they occur
Step 4
Safety monitoring
Regular blood tests will check for medication effects on your body
Any side effects will be recorded and monitored
Your kidney function and liver health will be regularly assessed
Step 5
Study completion
Final health assessments will be conducted
All test results will be recorded
Your participation will end after the final visit

Who can join the trial?

13 criteria

Age must be between 40 and 70 years old
Must provide written informed consent to participate in the study
Must have blood uric acid levels above 5mg/dl in tests from the last 6 months
Must meet at least one of these high cardiovascular risk conditions:
- Have a calculated 10-year risk of death from heart disease of:
  - More than 2.5% if under 50 years old
  - More than or equal to 5% if 50 years or older
  - Have documented history of:
    
    Stroke or mini-stroke
    Heart failure (mild to moderate)
    Poor blood flow to legs
    Irregular heartbeat (at any time)
    Have diabetes or high blood pressure with organ damage showing as:
    
    Stiff blood vessels
    Enlarged heart muscle
    Increased protein in urine
    Poor blood flow to ankles

Who cannot join the trial?

15 criteria

Current treatment with allopurinol or other medications that lower uric acid levels
Known allergy or sensitivity to allopurinol
Severe kidney disease (where kidney function is significantly impaired)
Severe liver disease that affects liver function
Active cancer or ongoing cancer treatment
Pregnancy or planning to become pregnant
Breastfeeding mothers
Participation in other clinical trials within the last 30 days
History of serious allergic reactions to medications
Inability to provide informed consent
Life expectancy less than 12 months due to any medical condition
Severe mental illness that could affect study participation
Alcohol or drug dependency
Recent major surgery (within last 3 months)
Unstable medical conditions that require frequent medication changes

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu
Verified
Wroclaw, Poland
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
Responsive
Warsaw, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland

Trial locations

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Investigated drugs

Allopurinol is a medication commonly used to lower uric acid levels in the blood. In this study, it is being investigated for its potential to reduce the risk of cardiovascular events (such as heart attacks and strokes) in patients who have a high or very high risk of cardiovascular problems, including those who have long-COVID syndrome. The medication works by blocking an enzyme that produces uric acid in the body, and researchers believe it may help protect the heart and blood vessels.

Allopurinol

What is already known about the treatment

Allopurinol - A widely used oral medication that belongs to the class of xanthine oxidase inhibitors, primarily prescribed for treating hyperuricemia (elevated uric acid levels in blood) and preventing gout. The medication works by blocking an enzyme called xanthine oxidase, which is responsible for the production of uric acid in the body, thereby reducing uric acid levels and potentially lowering cardiovascular risks. Recent clinical trials are investigating its potential benefits in patients with high cardiovascular risk factors, including those with conditions like hypertension, heart failure, and diabetes mellitus, as well as in patients with Long-COVID syndrome, suggesting its possible protective effects on the cardiovascular system beyond its traditional use in gout management.

Investigated diseases

Hyperuricemia
A condition where there is too much uric acid in the blood. The excess uric acid can form small crystals that deposit in various tissues of the body. The condition develops gradually and may remain asymptomatic for years.
Hypertension
A chronic condition where blood pressure in the arteries is persistently elevated. It develops over many years and typically causes no symptoms in its early stages. The condition puts extra strain on blood vessels and vital organs.
Ischemic Stroke
A condition where blood flow to part of the brain is blocked, causing brain tissue to become deprived of oxygen. It occurs when blood vessels supplying the brain become narrowed or blocked.
Intracerebral Hemorrhage
A condition where blood suddenly bursts into brain tissue, creating both bleeding inside the brain and pressure on the brain. It's a type of stroke that occurs when blood vessels within the brain rupture.
Transient Ischemic Attack (TIA)
A temporary period of symptoms similar to a stroke, occurring when blood flow to part of the brain is briefly interrupted. The symptoms typically resolve within 24 hours.
Heart Failure
A chronic condition where the heart cannot pump blood effectively enough to meet the body's needs. The heart continues working but becomes less efficient over time.