Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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 setembro de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

570

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: C. Michael Gibson, MS, MD Chief Executive Officer, MS, MD
  • Número de telefone: 617-307-5200
  • E-mail: info@baiminstitute.org

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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)

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: 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)
Outro: 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.
Sem intervenção: 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)

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Composite Guideline-Directed Medical Therapy (GDMT) Score
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Number of participants with all-cause mortality
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Safety Outcome Measure 1: Number of participants with acute kidney injury
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Baim Institute for Clinical Research

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de dezembro de 2026

Conclusão Primária (Estimado)

1 de maio de 2029

Conclusão do estudo (Estimado)

1 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

5 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de setembro de 2026

Primeira postagem (Real)

10 de setembro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • BICR 2026-02

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever