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NCT07811427Not yet recruitingPhase 4

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

Source: ClinicalTrials.gov · Last updated 10 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
570 (estimated)
First submitted
5 Jun 2026
Start date
Dec 2026
Primary completion date
May 2029
Lead sponsor
Baim Institute for Clinical Research
NCT number
NCT07811427

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 570
  • From Dec 2026 to the primary completion date, May 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Chronic hemodialysis or peritoneal dialysis or kidney transplant

Other illness

  • 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

Other

  • Advanced HF on inotrope support or requiring left ventricular assist device support.
  • Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.