Name: Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)
Creator: Ohio State University
Published: 2025-09-23
License: https://www.clinicaltrials.gov/about-site/terms-conditions#availability

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	O estudo clínico NCT07188545 (DASH-CKMH) para Cardiovascular Kidney Metabolic Syndrome está ativo, não recrutando. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui.

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Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH) 23.280.000 Randomizado Dados de vida real

Ativo, não recrutando

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O estudo clínico NCT07188545 (DASH-CKMH) é um estudo observacional para Cardiovascular Kidney Metabolic Syndrome. Seu status atual é: ativo, não recrutando. O estudo começou em 15 de setembro de 2025 e pretende incluir 23.280.000 participantes. Coordenado por a Universidade Estadual de Ohio e deve ser concluído em 30 de junho de 2029. Essas informações foram atualizadas no ClinicalTrials.gov em 23 de setembro de 2025.

Resumo

Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), which is a major determinant of premature morbidity and mortality. Poor CKMH may lead to cardiovascular-kidney-metabolic syndrome (CKMS) - the five-stage framework introduced by The American Heart Association (AHA) which ...Mostrar mais

Descrição detalhada

A target-trial design will be conducted in three sources of secondary data: 1)Merative Marketscan (claims-based data derived from commercial insurers), 2) All of Us (public database of Electronic Health Record \[EHR\] and survey data), and 3) LifeScale (EHR- derived from The Ohio State University Wexner Medical Center).

To construct a clinically similar comparator group, we opted for patients treated with active com...

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Título oficial

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

Condições médicas

Cardiovascular Kidney Metabolic Syndrome

Outros IDs do estudo

DASH-CKMH
STUDY20250372

Número NCT

NCT07188545

Data de início (real)

2025-09-15

Última atualização postada

2025-09-23

Data de conclusão (estimada)

2029-06-30

Inscrição (estimada)

23.280.000

Tipo de estudo

Observacional

Status

Ativo, não recrutando

Palavras-chave

GLP-1
SGLT-2
CKMS
CKMH
target trial
cardiovascular disease

Braços / Intervenções

Grupo de participantes/Braço	Intervenção/Tratamento
Marketscan Cohort Merative MarketScan Commercial Claims and Encounters and Medicare Supplemental Databases are nationally representative U.S. claims databases of commercially insured patients. The databases include deidentified inpatient, outpatient, prescription drug, procedure, and enrollment records of beneficiaries, dependents, and retirees covered under a variety of fee-for-service and managed care health plans. This database inc...Mostrar mais	Intervention GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin. Comparador Ativo DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate ...Mostrar mais
All of Us Cohort All of Us is a unique de-identified dataset administered by the U.S. National Institutes of Health (NIH) containing data from surveys, genomic analyses, electronic health records (EHR), physical measurements, and wearables to study the full range of factors that influence health and disease. All of Us is committed to recruiting a diverse participant pool that includes groups historically underrepresented in healthcar...Mostrar mais	Intervention GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin. Comparador Ativo DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate ...Mostrar mais
Lifescale Cohort LifeScale data is an institution-scale clinical data warehouse from the Ohio State University Wexner Medical Center (OSUWMC) and Nationwide Children's Hospital (NCH). The data is a limited de-identified copy of the OSU/NCH Caboodle clinical data warehouse mediated by an honest broker and governed under a comprehensive Institutional Review Board (IRB) protocol.	Intervention GLP-1RA and/or SGLT2i adult users with ≥1 prescription for the intervention GLP-1RA or SGLT2i medications (including combination drugs or mixed therapies with comparator medications). GLP-1RAs include: Exenatide, Liraglutide, Semaglutide, Dulaglutide, Lixisenatide, Albiglutide, Tirzepatide. SGLT2is include: Canagliflozin, Dapagliflozin, Bexagliflozin, Empagliflozin, Ertugliflozin, Sotagliflozin. Comparador Ativo DPP4i or Oral Obesity Agent adult users with ≥1 prescription for the comparator DPP4i or Oral Obesity Agent medications AND no intervention GLP-1RA or SGLT2i prescriptions in first 30 days of follow up. DPP4is include: Alogliptin, Saxagliptin, Linagliptin, Sitagliptin. Oral Obesity Agents include: Orlistat, Naltrexone-bupropion, Phentermine-topiramate, Phentermine, Diethylpropion, Bupropion (off-label), Topiramate ...Mostrar mais

O que o estudo está medindo?

Desfecho primário

Medida de desfecho	Descrição da medida	Prazo
3-Point major adverse cardiovascular event (3P-MACE)	Any of the following events: * Nonfatal myocardial infarction * Nonfatal stroke * Death within 14 days of myocardial infarction, ischemic stroke, heart failure, acute coronary syndrome, coronary artery bypass grafting, or percutaneous coronary intervention	Up to 5 years

Desfecho secundário

Medida de desfecho	Descrição da medida	Prazo
All-cause Mortality	evidence of death from any cause	Up to 5 years
Advancing CKMS stage	advancing from the baseline CKMS stage	Up to 5 Years
stroke		up to 5 years
Myocardial Infarction		up to 5 years
Incident coronary heart disease diagnosis		up to 5 years
Incident peripheral artery disease diagnosis		up to 5 years
Atrial fibrillation diagnosis		up to 5 years
renal failure		up to 5 years
kidney transplant		up to 5 years
kidney dialysis		up to 5 years
heart failure		up to 5 years

Assistente de participação

Critérios de elegibilidade

Idades elegíveis

Adulto, Idoso

Idade mínima

18 Years

Sexos elegíveis

Todos

Stage 1 or 2 CKMS at baseline
At least one prescription for an intervention or comparator medication after CKMS diagnosis
At least 180 days of continuous enrollment prior to the first prescription for any medication of interest (index date)
Age 18+ at index date

Stage 3 or 4 CKMS at baseline
Medications of interest during baseline period
Any history of type I diabetes
Cancer at baseline
Renal replacement therapy at baseline
End stage renal disease at baseline
Solid organ transplant at baseline
Missing sex

Universidade Estadual de Ohio

American Heart Association

Responsável pelo estudo

Daniel Walker, Investigador principal, Associate Professor and Vice Chair for Research, Ohio State University

Sem dados de contato.

1 Locais do estudo em 1 países

Estados Unidos

Ohio

Ohio State University, Columbus, Ohio, 43202, United States

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH) 23.280.000 Randomizado Dados de vida real

Critérios de inclusão

Critérios de exclusão