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Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC)
Sponsor: Baim Institute for Clinical Research
Summary
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
570
Start Date
2026-12
Completion Date
2029-05
Last Updated
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
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.
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.