Status:
UNKNOWN
Effects of Allopurinol on Inflammation and Ultrasonographic Changes in People With Elevated Uric Acid But no Symptoms
Lead Sponsor:
Instituto Nacional de Cardiologia Ignacio Chavez
Collaborating Sponsors:
Instituto Nacional de Rehabilitacion
Conditions:
Musculoskeletal Degeneration
Inflammation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 concentra...
Detailed Description
Gout is the most prevalent inflammatory rheumatological disease among young men, affecting about 4% of the general population. Caused by the deposit of monosodium urate (MSU) crystals which form becau...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04012294
Start Date
August 30 2019
End Date
February 28 2021
Last Update
January 23 2020
Active Locations (2)
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1
Instituto Nacional de Cardiología
Mexico City, Mexico, 14080
2
National Institute of Cardiology Mexico
Mexico City, Mexico, 14080