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Cardiovascular Diseases / Stage B Heart Failure / Type 2 Diabetes Mellitus (T2DM) · Observational Study
ClinicalTrials.gov · August 18, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a planned two-phase observational study evaluating cardiovascular effects of SGLT2 inhibitors and GLP-1 agonists in Korean patients with type 2 diabetes. No results are yet available. Phase 1 will retrospectively compare outcomes using electronic health records; Phase 2 will prospectively enroll ~100 participants starting SGLT2 inhibitor therapy and assess change in echocardiographic global longitudinal strain at 6 months as the primary endpoint.
Observational. Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases, Stage B Heart Failure; age from 19 Years. Intervention: Retrospective SGLT2 Inhibitor Cohort; Retrospective GLP-1 Receptor Agonist Cohort; Prospective SGLT2 Inhibitor Validation Cohort. Compared with: Phase 1: GLP-1 receptor agonists and unexposed patients (not detailed). Phase 2: No comparator; single-arm prospective cohort.. n = 100. 1 site: South Korea.
This is a planned two-phase observational study evaluating cardiovascular effects of SGLT2 inhibitors and GLP-1 agonists in Korean patients with type 2 diabetes. No results are yet available. Phase 1 will retrospectively compare outcomes using electronic health records; Phase 2 will prospectively enroll ~100 participants starting SGLT2 inhibitor therapy and assess change in echocardiographic global longitudinal strain at 6 months as the primary endpoint.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is in the planning stage with no results to inform practice. Once Phase 2 completes, the 6-month change in cardiac strain in uncontrolled SGLT2 inhibitor-treated patients may provide preliminary evidence of cardiac effects, but will require comparison data and validation to support clinical decision-making.
This is a registry record for a planned observational study with no results yet reported; Phase 2 is prospective and uncontrolled, examining surrogate cardiac endpoints in a small sample.
As stated by the source record.
Quoted from the source exactly as published.
This study is in the planning stage with no results to inform practice. Once Phase 2 completes, the 6-month change in cardiac strain in uncontrolled SGLT2 inhibitor-treated patients may provide preliminary evidence of cardiac effects, but will require comparison data and validation to support clinical decision-making.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07770737). This is a study registration, not published results. Lead sponsor: Dongtan Sacred Heart Hospital. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Type 2 Diabetes Mellitus (T2DM), Cardiovascular Diseases, Stage B Heart Failure. Primary outcome measures: Time to First Atherosclerotic Cardiovascular Disease Composite Event , From the index date until the first occurrence of acute myocardial infarction or ischemic stroke, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years; Time to First Hospitalization for Heart Failure , From the index date until the first hospitalization for heart failure, loss to follow-up, death, or the end of available database records, whichever occurs first, assessed up to 12 years; Change in Echocardiographic Global Longitudinal Strain , Baseline and 6 months after SGLT2 inhibitor initiation. Brief summary: This observational study will evaluate the cardiovascular effects of sodium-glucose cotransporter-2 inhibitors (SGLT2 inhibitors) and glucagon-like peptide-1 receptor agonists (GLP-1 receptor agonists) in Korean adults with type 2 diabetes. The study consists of two phases. Phase 1 will use de-identified electronic health record data from multiple Korean hospitals organized in a common data model. Cardiovascular outcomes, including myocardial infarction, ischemic stroke, and hospitalization for heart failure, will be compared among patients who started an SGLT2 inhibitor or a GLP-1 receptor agonist. Fractures, metabolic changes, and real-world medication use will also be evaluated. Phase 2 will prospectively enroll approximately 100 adults with type 2 diabetes who are starting an SGLT2 inhibitor as part of routine clinical care at Dongtan Sacred Heart Hospital. Participants will undergo electrocardiography, AI-based ECG analysis, echocardiography, blood and urine tests, and body composition assessment at baseline. Approximately 50 participants with stage B heart failure, defined as structural or functional heart abnormalities without heart failure symptoms, will undergo the same assessments after 6 months. The primary outcome of Phase 2 is the change in echocardiographic global longitudinal strain from baseline to 6 months. The study will also examine whether changes detected by AI-based ECG are associated with changes in echocardiographic measures of cardiac function. The study does not assign medications or alter routine treatment. All treatment decisions are made by the participants' treating physicians.
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