SAVE-Care (SGLT2i As Novel Gout Care) Trial
Massachusetts General Hospital
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.
Description
With the compelling premise as above, prospective gout-patient-specific RCTs for key gout disease endpoints are needed to provide high-level evidence needed to impact practice change with a great likelihood to revolutionize gout care as SGLT2i did in cardiology, diabetology, and nephrology. To that end, the investigators propose to conduct the first RCT of SGLT2i specifically among gout patients with hyperuricemia (SAVE-Care \[SGLT2i As Novel Gout Care\] Trial) for the endpoint of serum urate, the central outcome in clinical care, trials, and FDA approvals, as discussed above. Specifically, th…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 st…
Interventions
- DrugEmpagliflozin 10 mg
For the empagliflozin arm, participants will take 10 mg daily.
- DrugPlacebo
Participants in the placebo arm will take a placebo daily.
Location
- Massachusetts General HospitalBoston, Massachusetts