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โ† Trials
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SAVE-Care (Sodium Glucose Cotransporter-2 Inhibitors [SGLT2i] As Novel Gout Care) Trial

RecruitingPhase 4Ages 18 Years - 80 YearsAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 \[eGFR\] \<20ml/min 2. Colchicine or nonsteroidal anti-inflammatory drug \[NSAID\] prophylaxis 3. active cardiovascular disease \[CVD\], type-1 diabetes 4. pregnant and lactating women 5. Presence of a condition(s) or diagnosis, either physical or psychological, or physical exam finding that precludes participation. \[History of ketoacidosis, end-stage or decompensated liver disease, active cancer\] 6. Use of anti-obesity drugs 7. Basal-bolus or multiple daily injection insulin regimens, or loop diuretics
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What it tests

  • Empagliflozin 10 mg
  • Placebo
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Where

1 site
Massachusetts General Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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