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SAVE-Care (SGLT2i As Novel Gout Care) Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
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⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• Provision of signed and dated informed consent form.

• Fulfilling American College of Rheumatology \[ACR\]/European Alliance of Associations for Rheumatology \[EULAR\] gout criteria

• 1+ gout flares in last 12 months

• Serum urate level ≥ 6mg/dl

• Males and females; Age 18-80

• Willingness to adhere to the study intervention procedures.

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Ana D Fernandes, MA
adfernandes@mgh.harvard.edu
617-643-2140
Time Frame
Start Date: 2026-05-28
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 60
Treatments
Experimental: Empagliflozin 10mg
Participants in this arm will take empagliflozin 10mg daily
Placebo_comparator: Placebo
Participants in this arm will take a placebo daily
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov