GOaL Directed-STrategic Approach With New Disease-modifying theraApies to Reduce Kidney and Cardiovascular Risk in Patients With Diabetic Kidney Disease
GOLD-STANDARD is a pragmatic, open-label pilot randomized controlled trial evaluating the feasibility, safety, and implementation of an early goal-directed Cardio-Kidney-Metabolic (CKM) care strategy compared with usual care in adults with type 2 diabetes and diabetic kidney disease who are at increased cardiovascular risk. Participants will be followed for 12 months to assess treatment uptake, adherence, retention, and safety outcomes, and to inform the design of a future definitive trial.
• Age ≥ 18 years
• T2DM
• CKD (eGFR ≥ 25-60 mL/min/1.73 m² OR UACR ≥ 30 mg/g) - on screening labs
• High Cardiovascular (CV) Risk: Defined as a history of prior myocardial infarction (MI), stroke, or peripheral artery disease (PAD), or the presence of cardiovascular risk factors, (specifically age 40 years or older and at least one of the following: cholesterol above target (LDL≥1.8 mmol/L OR on cholesterol lowering medication - within past 24 months), hypertension (≥130/80 mmHg or on BPLMs), or atrial fibrillation.)
• Open to start new medications