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Recruiting
NCT06674109
SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial
Conditions: Gout and Hyperuricemia
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 60
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
SAVE-Care (Sodium Glucose Cotransporter-2 inhibitors \[SGLT2i\] As Novel Gout Care) Trial is a double-blind randomized placebo-controlled trial (RCT) designed to assess the effect of empagliflozin on serum urate \[SU\] levels of gout patients, as well as levels of highly-sensitivity C-reactive protein \[hsCRP\] and interleukin 6 \[IL-6\], and estimate gout flares over 3 months, in order to develop a full-scale RCT of clinical endpoints to directly inform gout care guidelines.
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Provision of signed and dated informed consent form.
2. Fulfilling American College of Rheumatology \[ACR\]/European Alliance of Associations for Rheumatology \[EULAR\] gout criteria
3. 1+ gout flares in last 12 months
4. Serum urate level ≥ 6mg/dl
5. Males and females; Age 18-80
6. Willingness to adhere to the study intervention procedures.
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Estimated Glomerular Filtration Rate \[eGFR\] \
Source: ClinicalTrials.gov (NCT06674109). StuddyBuddy aggregates publicly available trial information.
