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 study about?

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.

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.

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)

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

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

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
4 Wojskowy SzpitaKliniczny Z Polikliniką Samodzielny Publiczny ZakładOpieki ZdrowotneWe Wrocławiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy	Warsaw	Poland
Santa Sp. z o.o.	Lodz	Poland
Clinical Medical Research Sp. z o.o.	Katowice	Poland
Santa Sp. z o.o. sp. K.Polimedica PTG Kielce	Kielce	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Salve Medica Sp. z o.o. S.K.	Lodz	Poland
Pzlgjnwdws Cjwywjt Bwcoi Pagqjojzwqwa I Lhkofyqq Sko z odik	Warsaw	Poland
Iepursjxzgpi Skvyfwhdoylqtbe Ppaumgby Lrqizgcw dg ns mepq Pphdg Luglikyvvjj	Slupsk	Poland
Mhzylszls Iriavgyvr	Jaksice	Poland
Uthelngvjhsuie Cpuwkot Kxqcezdbo	Gdansk	Poland
Srgldyxlmvx Pmosukzud Shzgqpy Kdacdsbzw Imadmramdfn Mngxgckhxdl Sop W Koxqljnoqk	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.03.2023

Trial locations

Investigated drugs:

Allopurinol

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.

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.

Peripheral Arterial Disease – A circulatory condition where narrowed arteries reduce blood flow to the limbs. The condition develops gradually as arteries become narrowed due to buildup of fatty deposits.

Atrial Fibrillation – An irregular and often rapid heart rhythm that occurs when the upper chambers of the heart beat out of coordination with the lower chambers. The condition affects the heart’s ability to pump blood efficiently.

Diabetes Mellitus – A chronic condition affecting how the body processes blood sugar (glucose). The body either doesn’t make enough insulin or cannot effectively use the insulin it produces.

Trial ID:

2024-517610-15-00

Protocol code:

2022/ABM/01/00027

NCT ID:

NCT05943821

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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