SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
NCT07482020 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2026-03-19
Summary
Heart failure is the most important clinical endpoint event in atrial fibrillation (AF). Patients with AF complicated by heart failure have a significantly higher risk of all-cause mortality and cardiovascular mortality compared to those without heart failure. Abnormal left atrial function is an important mechanism leading to the occurrence of AF-related heart failure. Therefore, it is essential to find drugs that can improve left atrial function to prevent heart failure in patients with AF. Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are important drugs for regulating metabolic abnormalities. Studies have found that these drugs also reduce the risk of new-onset AF in patients with heart failure. Thus, the investigators hypothesize that SGLT2i may be able to regulate left atrial function.
This study is a multicenter randomized controlled trial using three-dimensional speckle tracking echocardiography to investigate whether SGLT2i can improve left atrial function and prevent heart failure in patients with paroxysmal AF who have hypertension and metabolic disorders, compared to placebo. The investigators also observed the effects of SGLT2i on cardiovascular and metabolic risk factors. The investigator team has a solid foundation in the field of cardiovascular metabolism, having completed the evaluation of left atrial function in paroxysmal AF using three-dimensional speckle tracking technology over the past three years. This study is the first to propose that SGLT2i can improve left atrial function in paroxysmal AF patients with metabolic abnormalities, which is of great significance for preventing heart failure in this type of AF.
Conditions
- Atrial Fibrillation (AF)
- Hypertension
Interventions
- DRUG
-
SGLT-2 inhibitors
empagliflozin (10mg qd)
- DRUG
-
PLACEBO
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
collaborator OTHER -
Shanghai 10th People's Hospital
collaborator OTHER -
Huashan Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-03-01
- Primary Completion
- 2026-12-30
- Completion
- 2027-06-30
Countries
- China
Study Locations
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