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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) (HOLISTIC)

3 de septiembre de 2026 actualizado por: Baim Institute for Clinical Research
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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

The study is designed to provide evidence for MCM versus UCM to improve a composite GDMT score, reduce major kidney and cardiovascular risks, reduce hospitalizations (and thereby healthcare costs), and improve QoL, for patients with T2D and high and very high KDIGO CKD risk. These Specific Aims address critical gaps including lack of patient access to subspecialists, PCC and patient inertia, and inadequate infrastructure to optimize nutrition. The MCM is designed to increase GDMT uptake across the health system, PCC, and patient domains. Outside the US, MCMs in patients with CKD and T2D have shown promise by reducing CKM risk factors, healthcare costs, subspecialty clinic visits, and hospitalizations. Given lack of patient access to subspecialists in the US,32 especially nephrologists, a specialist-dominant model for GDMT uptake and optimization may not be feasible in many health systems. Notably, PCCs are also in shortage by workforce capacity, and they have large patient panels, severe time constraints, and competing priorities. Therefore, maintaining vital PCC and patient relationships, while bringing a primary-care-based CKM pharmacist onboard with consulting subspecialists, is a way forward. HOLISTIC will answer a call for research on team-based primary care to alleviate physician shortages for under-served health needs such as T2D and CKD. This approach can also capitalize on successes pioneered by telehealth during the COVID-19 pandemic for complex chronic conditions by assisting PCCs through pharmacist led CMM. Finally, it allows a strategic re-purposing of existing resources (pharmacist clinicians) who can support PCCs and lead CMM and GDMT deployment in a risk-appropriate and timely fashion, to demonstrate value to this alternate model across optimal care delivery, clinical outcomes, cost savings/return on investment.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

570

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD
  • Número de teléfono: 617-307-5200
  • Correo electrónico: info@baiminstitute.org

Copia de seguridad de contactos de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Provide written informed consent
  2. 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.

Exclusion Criteria:

  1. Advanced HF on inotrope support or requiring left ventricular assist device support.
  2. Chronic hemodialysis or peritoneal dialysis or kidney transplant
  3. Life expectancy of <1-year, and vulnerable populations such as pregnant women, incarcerated individuals, or those with active psychiatric illness.
  4. 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
  5. 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
  6. Personnel, or any relative of personnel, of the Sponsor, the CRO, or the investigative site(s)

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: multidisciplinary care model (MCM) intervention
This model/arm will include Primary Care Clinician (PCC) delivered care assisted by a Multidisciplinary Heart-Kidney-Diabetes Care Team Model (MCM)
Otro: 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.
Sin intervención: a usual care model (UCM)
This model/arm will include PCC delivered care with as-needed Local Specialist Support, representing the Usual Care Model (UCM)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
Periodo de tiempo: Baseline to 12 months
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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with all-cause mortality
Periodo de tiempo: 12 Months
Number of participants who die from any cause during the 12-month follow-up.
12 Months
Outcome Measure: Number of Participants with Worsening Kidney Disease
Periodo de tiempo: 12 Months
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.
12 Months
Outcome Measure: Number of Participants with Worsening Heart Failure Events
Periodo de tiempo: 12 Months
Number of participants experiencing worsening heart failure, including heart failure hospitalization or urgent heart failure visit.
12 Months
Outcome Measure: Major Adverse Cardiovascular Events (MACE)
Periodo de tiempo: 12 Months
Number of participants experiencing major adverse cardiovascular events, defined as the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke
12 Months
Outcome Measure: Change from Baseline in Kidney Disease Quality of Life (KDQOL-36) Summary Score
Periodo de tiempo: Baseline and 12 Months
Mean change from baseline to Month 12 in the Kidney Disease Quality of Life (KDQOL-36) summary score. Unit of Measure: Points
Baseline and 12 Months
Change in PREVENT-CVD Predicted Cardiovascular Risk Score
Periodo de tiempo: 12 Months

Change from baseline to 12 months in predicted cardiovascular risk estimated using the PREVENT-CVD risk calculator among participants without established cardiovascular disease at baseline.

Unit of Measure: Percentage points (%)
12 Months
eGFR Total Slope
Periodo de tiempo: 12 Months

Annualized rate of change in estimated glomerular filtration rate (eGFR) from baseline through 12 months.

Unit of Measure: mL/min/1.73 m²/year
12 Months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Safety Outcome Measure 1: Number of participants with acute kidney injury
Periodo de tiempo: 12 Months

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
12 Months
Safety Outcome Measure 2: Number of participants with hypotension
Periodo de tiempo: 12 Months

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
12 Months
Safety Outcome Measure: Number of participants with volume depletion
Periodo de tiempo: 12 Months

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
12 Months
Safety Outcome Measure Title: Number of participants with hyperkalemia
Periodo de tiempo: 12 Months

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
12 Months
Safety Outcome Measure: Number of participants with hypoglycemia
Periodo de tiempo: 12 Months

Hypoglycemia defined according to American Diabetes Association (ADA) Standards of Care as blood glucose <70 mg/dL (Level 1 hypoglycemia). Severe hypoglycemia is defined as an event requiring assistance from another person.

Unit of Measure: Participants with event
12 Months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Baim Institute for Clinical Research

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de diciembre de 2026

Finalización primaria (Estimado)

1 de mayo de 2029

Finalización del estudio (Estimado)

1 de mayo de 2029

Fechas de registro del estudio

Enviado por primera vez

5 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • BICR 2026-02

Plan de datos de participantes individuales (IPD)

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INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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