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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing SGLT2 inhibitors — a drug class originally developed for diabetes and heart failure — as a potential gout treatment; can you explain how these drugs are thought to lower uric acid levels, and whether that mechanism makes sense given my specific situation?
2Since this is a Phase 4 trial, the drugs being tested are already approved for other conditions — does that mean we have a clearer picture of their safety profile compared to an earlier-phase study, and are there any known risks I should be aware of given my current health?
3The trial is measuring changes in serum urate levels as its main outcome — how does my current uric acid number compare to what researchers would typically be trying to achieve, and would that kind of change actually matter for my symptoms?
4Before considering this trial, should I first try standard urate-lowering therapies like allopurinol or febuxostat, or is there a reason this approach might be worth exploring at this point in my treatment?
5This trial is actively recruiting right now — what would my commitments actually look like in terms of visits, blood tests, or medication changes, and how might that fit with my current treatment plan and daily life?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Colchicine or nonsteroidal anti-inflammatory drug \[NSAID\] prophylaxis
. active cardiovascular disease \[CVD\], type-1 diabetes
. pregnant and lactating women
. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. \[History of ketoacidosis, end-stage or decompensated liver disease, active cancer\]
. Use of anti-obesity drugs
. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics