Gout, Hypertriglyceridemia, Pericarditis
Conditions
Keywords
Colchicine, Hypertriglyceridemia, Apolipoprotein CIII
Brief summary
The aim of this trial will be to determine an effect-size for the administration of chronic low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density lipoproteins (VLDL), and apolipoprotein CIII (apoCIII) in human subjects over a period of 4-6 weeks.
Detailed description
The aim of this proposal will be to show, in a translational fashion, a relationship between colchicine and reduction of factors affecting triglyceride metabolism, especially apoCIII and VLDL levels. We envision colchicine as playing a role in identifying and elucidating a new mechanism for lowering TG levels, which may have a great impact on targeting patients who have not met non-HDL goals according to Adult Treatment Panel III (ATPIII guidelines) or at risk for hypertriglyceridemia-induced pancreatitis \[11\]. We will accomplish this by conducting a prospective cohort clinical trial of low-dose colchicine in hypertriglyceridemic patients to assess percent (%) reduction of apoCIII, VLDL, and TG. Secondary endpoints will be to observe the effects of colchicine on apoA, apoB, HDL, low-density lipoprotein (LDL), and total cholesterol (TC).
Interventions
DRUGColchicine
Sponsors
Scripps Translational Science Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Acute new-onset pericarditis or recurrent pericarditis (≥2 following criteria) * Sharp and pleuritic chest pain improved or relieved by sitting up and leaning forward * A pericardial friction rub * Electrocardiogram (EKG) findings of diffuse ST-segment elevations or PR depression * New or worsening pericardial effusion visualized on echocardiogram. OR •Acute gouty arthritis (according to the ACR; ≥1 of following criteria: * Joint fluid containing urate crystals * Tophus proved to contain urate crystals by chemical means * Polarized light microscopy * Presence of six of the following in the absence of crystal identification: * \>1 attack of acute arthritis * Maximum inflammation developed in 1 day * Monoarthritis attack * Redness observed over joints * 1st metatarsal joint painful or swollen * Unilateral 1st metatarsal joint attack * Unilateral tarsal joint attack * Tophus (suspected) * Hyperuricemia * Asymmetric swelling within a joint visible on physical examination or radiography * Subcortical cysts without erosions visible on radiography * Monosodium urate monohydrate microcrystals in joint fluid during attack * Joint fluid culture negative for organisms during attack. If N \< 10 after 3 weeks of trial initiation, then employ enrollment strategy #2 Enrollment strategy #2: * History of hypertriglyceridemia (TG ≥ 150 mg/dL) AND * Age ≥ 18 years old * Capable of providing informed consent * Capable of taking Colchicine 0.6-1.2 mg/day orally for 6 weeks * Capable of providing a blood sample
Exclusion criteria
* Colchicine use \< 8 weeks from baseline VAP panel * Pregnant or female of child bearing age * On corticosteroid therapy or corticosteroid use \< 4 weeks from baseline VAP panel * History of statin myopathy or hepatotoxicity * History of colchicine intolerance or hypersensitivity * Severe end-stage renal disease (eGFR ≤ 20 mL/min/1.73 m2) or requiring dialysis * Hepatic Impairment (Child-Pugh class B or C) * Myopericarditis (If TnI is elevated on presentation of acute pericarditis) * Inflammatory Bowel Disease * Tuberculous, neoplastic, or purulent pericarditis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in ApoCIII levels | 6 weeks |
| Reduction of triglycerides and very low density lipoprotein (VLDL) levels | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of Apolipoprotein A and Apolipoprotein B via Vertical Auto Profile (VAP) | 6 weeks |
Countries
United States
Outcome results
None listed