Heart-Kidney-Diabetes Multidisciplinary Care MOdels for CardiovascuLar Health In Patients With Chronic Kidney DiSease and Diabetes: A PragmaTIC Cluster Randomized Controlled Trial (HOLISTIC)

NCT07811427 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: BICR 2026-02
• Study Type: interventional
• Target: 570
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Kidney Disease; Type II Diabetes

Keywords

Cardiovascular-kidney-metabolic; Multidisciplinary Care Model; Guideline Directed Medical Therapies

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (7)

• Number of participants with all-cause mortality

  12 Months

• Outcome Measure: Number of Participants with Worsening Kidney Disease

  12 Months

• Outcome Measure: Number of Participants with Worsening Heart Failure Events

  12 Months

• Outcome Measure: Major Adverse Cardiovascular Events (MACE)

  12 Months

• Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score

  Baseline and 12 Months

Other Outcomes (5)

• Safety Outcome Measure 1: Number of participants with acute kidney injury

  12 Months

• Safety Outcome Measure 2: Number of participants with hypotension

  12 Months

• Safety Outcome Measure: Number of participants with volume depletion

  12 Months

Study Arms (2)

multidisciplinary care model (MCM) intervention

ACTIVE COMPARATOR

This model/arm will include Primary Care Clinician (PCC) delivered care assisted by a Multidisciplinary Heart-Kidney-Diabetes Care Team Model (MCM)

Other: 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.

a usual care model (UCM)

NO INTERVENTION

This model/arm will include PCC delivered care with as-needed Local Specialist Support, representing the Usual Care Model (UCM)

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. OTHER

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.

multidisciplinary care model (MCM) intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent
• 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.

You may not qualify if:

• 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
• Any condition that would interfere with the patient's ability to comply with study instructions, might confound the interpretation of the study, or put the patient at risk
• Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)

Sponsors & Collaborators

• Baim Institute for Clinical Research: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD

CONTACT

617-307-5200; info@baiminstitute.org

Patricia Wedge M Chief Operating Officer, RN, BSN, CCRC

CONTACT

617-307-5320; patricia.wedge@baiminstitute.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed study uses an intervention that requires clinic-level randomization, which minimizes contamination between patients cared for within the same clinic. Therefore, we propose to conduct a cluster randomized, two-group trial of a MCM versus UCM. Each of the 6 health systems will have 6 clinics, with each clinic representing a cluster as the unit of randomization. Block randomization will be completed using a computer-generated algorithm to allocate clinics within the site randomly at a 1:1 ratio to MCM or UCM. The analysis of the primary outcome will be stratified by study site. Study outcomes pertain to the individual participant rather than the clinic.

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: September 10, 2026

Record last verified: 2026-09