Actively Recruiting

Phase 2
Age: 18Years - 80Years
All Genders
NCT07482020

SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism

Led by Huashan Hospital · Updated on 2026-03-19

66

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

Sponsors

H

Huashan Hospital

Lead Sponsor

S

Shanghai Zhongshan Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 80 years
  • Diagnosis of paroxysmal atrial fibrillation confirmed by ECG, 24-hour Holter, or handheld ECG
  • Hypertension with ongoing antihypertensive treatment
  • Diabetes under treatment or prediabetes with HbA1c between 6.1% and 6.4% in past 3 months
Not Eligible

You will not qualify if you...

  • Atrial fibrillation caused by severe mitral stenosis
  • Atrial fibrillation with severe mitral regurgitation and severe tricuspid regurgitation
  • Clinical diagnosis of heart failure (preserved or reduced ejection fraction)
  • Special cardiomyopathies such as amyloid cardiomyopathy, Fabry disease, muscular dystrophy, hypertrophic obstructive cardiomyopathy
  • History of myocardial infarction within the past 3 months
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Affiliated Huashan Hospital, Cardiology Department

Shanghai, Shanghai Municipality, China, 200036

Actively Recruiting

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Research Team

L

Liwen Bao, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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