Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms

• Status: Recruiting
• Trial end date: 2021-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Hyperuricemia is a metabolic alteration defined as the presence of serum urate levels higher than 7 mg/dL. This has proven to be the maximum limit of solubility of urate in serum, any higher concentration leads to precipitation and eventually to the formation of monosodium urate (MSU) crystals. The accumulation of said crystals can manifest as gouty arthritis, uric acid nephropathy, urolithiasis or chronic tophaceous gout.

A strong relation between hyperuricemia and other chronic degenerative diseases, including diabetes mellitus, systemic arterial hypertension, obesity and metabolic syndrome, has been consistently proven.

Hypouricemic pharmacological agents have shown a decrease in cardiovascular complications and death in patients with gout.

A series of studies conducted on individuals with asymptomatic hyperuricemia using musculoskeletal ultrasound (MSUS) have shown the presence of morphostructural changes suggestive of MSU crystal deposits, combined with an elevation in a series of inflammation markers to a degree similar to those found in patients with chronic gout.

Even though, there is evidence of morphostructural damage in individuals with asymptomatic hyperuricemia, there are no clinical, laboratorial or imaging parameters that indicate when hypouricemic treatment should be started.

This clinical trial is proposed as a proof of concept which is looking to evaluate if treatment with allopurinol induces changes in levels of inflammatory markers in individuals with asymptomatic hyperuricemia and morphostructural changes suggestive of MSU crystal deposits. this proof of concept is not looking to measure the efficiency, effectiveness or security of the treatment.

Our Hypothesis is that Individuals with asymptomatic hyperuricemia and morphostructural changes evidenced by MSUS (double contour sing, tophi, aggregates) will show a decent in inflammatory markers and their morphostructural changes will diminish or revert after treatment with allopurinol.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez
• Collaborator: Instituto Nacional de Rehabilitacion
• Treatments: Allopurinol

Criteria

Inclusion Criteria:

• Individuals with two urate determinations >7 mg/dL in the last year and no clinical sign, past or present, suggestive of joint inflammation (acute gout attack), urolithiasis or uric acid nephropathy

• Over 18 years of age

• Residents of Mexico City or its metropolitan area

• Individuals with a signed informed consent form for the participation in the clinical trial

Exclusion Criteria:

• Individuals with joint inflammation suggestive of gout during the clinical evaluation

• Patients without elemental ultrasonographic lesions (double contour sign, aggregates, tophi) on the first metatarsophalangeal joint, knee, ankle or the tendons of the quadriceps, patella, and calcaneus when evaluated by MSUS

• Patients taking thiazides

• Patients with history of stroke or coronary artery disease in the last year

• Patients with osteoarthritis be it by clinical presentation or imaging

• Pregnant women

• Neoplasms

• Known Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) , Human immunodeficiency Virus (HIV) infection, or any other know active infections

• Autoimmune or autoinflammatory disease

• Allopurinol hypersensitivity or allergy

• Deteriorated kidney function (Glomerular Filtration Rate (GFR) <50 mL/min/1.73m^2)

• Patients taking azathioprine

• Functional New York Heart Association (NYHA) score of II or more