Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
American Heart Association
Conditions:
Cardiovascular Kidney Metabolic Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
Complex pathophysiological interactions among obesity, metabolic risk factors, chronic kidney disease (CKD), and the cardiovascular system lead to poor cardiovascular-kidney-metabolic health (CKMH), w...
Detailed Description
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 Heal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
23280000 Patients enrolled
Trial Details
Trial ID
NCT07188545
Start Date
September 15 2025
End Date
June 30 2029
Last Update
September 23 2025
Active Locations (1)
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1
Ohio State University
Columbus, Ohio, United States, 43202