ABSTRACT

Patients with severe complicated gout and complex chronic multimorbidity — including chronic kidney disease, heart failure, decompensated cirrhosis, and adrenal insufficiency — are often excluded from international clinical studies. This is true even though the treatment goals themselves have already been shown to be achievable, such as dissolving urate crystals [4–11], delaying dialysis [12, 13], reducing heart failure decompensation [14–16], and achieving hepatic recompensation [17, 20]. The problem is that these goals were demonstrated in selected study populations, under research conditions that are very different from real-world practice.

Even in the 100 patients included in the Vien Gut study program — published at ACR 2017 [4], EULAR 2019 [5], ACR 2020 [6], and in Seminars in Arthritis and Rheumatism 2022 [7], with Prof. Thomas Bardin as first author — although there were 32 cases of hypertension, 7 cases of type 2 diabetes, 31 cases of dyslipidemia, 47 cases of coronary artery disease, and 16 patients with long-term corticosteroid dependence, the study still required eGFR > 60 mL/min in order to avoid the confounding effect of anti-inflammatory pain medications on kidney function. Therefore, this was still not a broadly representative population of patients with severe gout and complex multimorbidity.

Document C.1 is intended to answer that question. More specifically, C.1 explains how Vien Gut organizes treatment to dissolve urate crystal deposits in patients who are within the coverage of current guidelines, in patients with chronic kidney disease from stage 3 to end-stage disease, in patients ranging from ischemic heart disease to heart failure with reduced ejection fraction, in patients with liver fibrosis F2 and F3 to decompensated cirrhosis, and in patients with advanced stages of many other chronic diseases. It also presents the process of measurement, longitudinal follow-up, and confirmation of crystal-free status at the time of assessment; the role of surgery in gout; and the guideline-based principle that gout can be cured, which serves as the basis for certifying gout remission at the time of assessment.

From July 2024 to March 2026, 155 patients were confirmed as crystal-free. This is still single-center data and needs further standardization and multicenter validation. The first step is the ReViGore40 study (NCT06669000) [23], led by Prof. Pascal Richette.

The other major comorbidity axes are presented separately: C.2 on delaying dialysis, C.3 on reducing heart failure decompensation, and C.4 on hepatic recompensation. In all three documents, gout-related complications remain the underlying disease context.

BACKGROUND

Vien Gut was founded in 2007 in Ho Chi Minh City, Vietnam, with the initial goal of finding solutions for patients with severe gout complications who were living in pain, deadlock, and despair. When Vien Gut began operating, Vietnam was still a low-income country according to the World Bank, with limited resources and a shortage of deeply specialized physicians. Vien Gut also could not recruit rheumatologists to work full-time, and instead relied on retired general internal medicine physicians who were willing to work full-time at Vien Gut General Clinic.

At first, this was simply a human-resource limitation typical of an LMIC setting, not a deliberate architectural decision. But after more than a decade of longitudinal practice, that limitation became one of the most important architectural findings: general internists with adequate continuing medical education were actually well suited for the role of integrated clinical coordinator — the Clinical Conductor — especially for patients who fall outside the coverage zone of gout treatment guidelines.

In 2014, with academic support from Professor Thomas Bardin, co-author of the 2006 EULAR gout management guideline, Vien Gut fully adopted the EULAR recommendations for gout management, including the 2016 and 2023 updates, as well as the ACR 2020 guideline. Even so, the 2006 EULAR guideline had the strongest influence on Vien Gut’s direction, because it emphasized that gout treatment must focus on dissolving deposited urate crystals. Recommendation 8 of EULAR 2006 clearly states the principle: “Gout is a true crystal deposition disease, occurring only in the presence of urate crystals. If crystal formation is prevented and existing crystals are dissolved, the patient is essentially cured.”

Although the first international study using a treat-to-target allopurinol strategy in 100 severe gout patients at Vien Gut had to exclude patients with GFR < 60 mL/min, Vien Gut still had to design the HOW layer so that the goal of dissolving urate crystal deposits through a safe and effective treat-to-target strategy could also be applied to patients with severe complicated gout and complex chronic multimorbidity, such as end-stage chronic kidney disease before dialysis, chronic heart failure, decompensated cirrhosis, advanced type 2 diabetes, and severe stages of many other chronic diseases.

General internists in the Vien Gut Model are continuously updated through CME programs in the relevant specialties — KDIGO for kidney disease, AHA/ACC/HFSA for heart disease, Baveno VII for liver disease, ADA for diabetes, and the Endocrine Society for adrenal insufficiency — so that they have sufficient expertise to examine, diagnose, and provide outpatient treatment for patients with severe complicated gout and complex chronic multimorbidity. What makes them different from outpatient physicians in fragmented care models, who often have to work alone, is that Vien Gut physicians are supported by a multidisciplinary team: imaging specialists, laboratory staff, clinical pharmacists, medical secretaries, nurses, outpatient care staff, planning staff, and media staff who take standardized clinical photographs of gout tophi before and after treatment.

Although the treating physicians and multidisciplinary team at Vien Gut are the people who directly carry out examination, diagnosis, treatment, and outpatient care management for gout and comorbid conditions, they can only work effectively within an integrated care model that has operational layers already designed in advance: risk stratification, longitudinal follow-up databases, action thresholds, referral safety valves, assessment criteria, follow-up schedules, and training processes that allow patients to participate in treatment. These are the necessary and sufficient conditions that allow Vien Gut to pursue the goal of dissolving urate crystal deposits in gout patients, from uncomplicated cases to severe complicated gout with complex chronic multimorbidity. The final goal is to help patients who are persistent enough achieve crystal-free status at the time of assessment, and then continue lifelong urate-lowering therapy so that urate crystals never redeposit.

Document C.1 — implementing the treatment goal of dissolving deposited urate crystals in gout patients, from uncomplicated cases to severe complicated disease — will be presented in three parts.