Our overarching goal of this study is to provide rigorous evidence for using an accelerated risk-based approach to implementing guideline directed medical therapies (GDMT) using a multidisciplinary care model (MCM) versus a usual care model (UCM) to improve a composite GDMT score, reduce kidney disease and heart failure (HF) events, hospitalizations, and total healthcare costs for patients with type 2 diabetes (T2D) and CKD with high- to very-high Kidney Disease: Improving Global Outcomes (KDIGO) risk.
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Adults ≥18 years of age with T2D and CKD at high or very high KDIGO risk (Figure A1): eGFR 45-59 mL/min/1.73 m2 and UACR >300 mg/g OR eGFR 30-44 mL/min/1.73 m2 and UACR >30 mg/g OR any eGFR <30 mL/min/1.73 m2.
Advanced HF on inotrope support or requiring left ventricular assist device support.
Chronic hemodialysis or peritoneal dialysis or kidney transplant
Life expectancy of <1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.
Unreliable or non-compliant, including patients with known history of alcoholism, drug abuse, or serious psychiatric disorder; as well as patients unwilling to abide by the requirements of the protocol
Parallel
The intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
Other interventionThe intervention with the MCM is Kidney-Heart GDMT initiation and titration for dose optimization (as clinically tolerated), within 4 months of enrollment in the study.
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
Composite GDMT calculated from baseline to Month 12 across five pre-defined medication classes (RAS inhibitors, SGLT2 inhibitors, GLP-1 receptor antagonists, non-steroidal mineralocorticoid receptor antagonists, and statins). The score is the sum of baseline use and changes during follow-up (+1 for initiation of a medication class and -1 for discontinuation). This represents a single composite outcome.
Number of participants with all-cause mortality
Number of participants who die from any cause during the 12-month follow-up.
Outcome Measure: Number of Participants with Worsening Kidney Disease
Number of participants experiencing worsening kidney disease, defined according to the study protocol as ≥40% decline in estimated glomerular filtration rate (eGFR) from enrollment, eGFR \<10 mL/min/1.73 m², initiation of dialysis, or kidney transplantation.
Outcome Measure: Number of Participants with Worsening Heart Failure Events
Number of participants experiencing worsening heart failure, including heart failure hospitalization or urgent heart failure visit.
Outcome Measure: Major Adverse Cardiovascular Events (MACE)
Number of participants experiencing major adverse cardiovascular events, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
Safety Outcome Measure 1: Number of participants with acute kidney injury
Acute kidney injury defined according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria as an increase in serum creatinine of ≥0.3 mg/dL within 48 hours or an increase in serum creatinine to ≥1.5 times baseline within 7 days. Unit of Measure: Participants with event
Safety Outcome Measure 2: Number of participants with hypotension
Hypotension defined as systolic blood pressure \<90 mmHg or symptomatic hypotension requiring clinical intervention, medication adjustment, or study drug discontinuation. Unit of Measure: Participants with event
Safety Outcome Measure: Number of participants with volume depletion
Volume depletion defined as clinical evidence of dehydration or hypovolemia requiring fluid replacement, medication adjustment, emergency department evaluation, or hospitalization. Unit of Measure: Participants with event
Safety Outcome Measure Title: Number of participants with hyperkalemia
Hyperkalemia defined as clinically significant elevation in serum potassium requiring clinical intervention, medication adjustment, emergency department evaluation, or hospitalization, according to the study protocol. Unit of Measure: Participants with event
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