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NCT07188545 · ClinicalTrials.gov registry record
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)
A clinical trial of Cardiovascular-kidney-metabolic Syndrome, sponsored by Ohio State University.
- Active
- Registry status
- 23,280,000
- Enrollment target
- 1
- Study location
NCT07188545: Active study of Cardiovascular-kidney-metabolic Syndrome, sponsored by Ohio State University.
NCT07188545 is a study of Cardiovascular-kidney-metabolic Syndrome that is active but no longer recruiting, run by Ohio State University. The registered enrollment target is 23,280,000 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07188545, a study of Cardiovascular-kidney-metabolic Syndrome, is active but no longer recruiting, sponsored by Ohio State University.
- ACTIVE NOT RECRUITING
- Registry status
- 23,280,000 participants
- Enrollment target
- 1
- Study location
Study 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), 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 accounts for the critical overlap between cardiorenal syndrome and cardiometabolic disease. Evidence from randomized controlled trials shows glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose co-transporter-2 inhibitors (SGLT2is) may improve CKMH in individuals with Type 2 Diabetes (T2D) and/ or obesity. However, there is modest evidence suggesting differential effectiveness of GLP-1RA and SGLT2i drugs between males and females. The extent of these sex-based differences is currently unknown. In part, this may be due to underrepresentation of females in clinical trials. Exploring sex-based differences in GLP-1RA and SGLT2i treatment on CKMH outcomes is important to inform CKMS treatment and equity in CKMH. Robust secondary data sources present the opportunity to elucidate sex heterogeneity in GLP-1RA and SGLT2i treatment on CKMH outcomes. Using a target-trial emulation design, this study aims to observe differences in long-term CKMH outcomes between patients treated by GLP-1RA and SGLT2i medications versus those treated with active comparator medications, and whether there is an observed interaction between sex and treatment.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Active Comparator
- DRUG Intervention
Study Locations (1)
Ohio
- Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23,280,000 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2029-06-30 |
What the registry record for NCT07188545 still lists
NCT07188545 is an observational study that tracks outcomes without assigning an intervention. Its 23,280,000 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Cardiovascular-kidney-metabolic Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Active Comparator is the first listed.
NCT07188545 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07188545 about?
NCT07188545 is a clinical study titled "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)". 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 cardiovascul...
What is the current status of trial NCT07188545?
This trial is currently active not recruiting. The enrollment target is 23,280,000 participants. The study started on 2025-09-15. Estimated completion is 2029-06-30.
What conditions does trial NCT07188545 study?
This clinical trial studies the following conditions: Cardiovascular-kidney-metabolic Syndrome.
What interventions are being tested in trial NCT07188545?
The interventions under investigation include: Active Comparator (DRUG), Intervention (DRUG).
Who is sponsoring clinical trial NCT07188545?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07188545 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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