SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• Patients aged 18-80 years, treated in the outpatient or inpatient departments of each research center and included in the AF database.
Patients with paroxysmal AF confirmed by 12-lead electrocardiogram, 24-hour Holter monitoring, or handheld electrocardiogram devices.
Patients with hypertension who have already started antihypertensive treatment.
Patients with diabetes who have already started antidiabetic treatment, or patients with prediabetes who have not received antidiabetic treatment but have an HbA1c level within the range of 6.1-6.4% in the past three months.
Disqualifiers
• Atrial fibrillation caused by severe mitral stenosis.
Atrial fibrillation with severe mitral regurgitation and severe tricuspid regurgitation.
Patients who have been clinically diagnosed with heart failure (heart failure with preserved ejection fraction or heart failure with reduced ejection fraction).
Special types of cardiomyopathy: amyloid cardiomyopathy, Fabry disease, muscular dystrophy, hypertrophic obstructive cardiomyopathy, etc.
Trial design
Design model
Parallel
Treatments tested in this trial
SGLT-2 inhibitors
Drugempagliflozin (10mg qd)
Placebo
DrugPLACEBO
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: SGLT2 i TREATMENTActive comparator 1 intervention
Group B: PLACEBOPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
LA strain （LASI）
Using three-dimensional speckle tracking technology to measure longitudinal strain during the reservoir phase (LASr).Using TDI to measure E/e'. The LASI is calculated by these two parameter and can indicate left atrial strain.
Time frame
from enrollment to the end of treatment at 12 monthsSecondary outcomes
1
circumferential strain (LASr-c)
Using three-dimensional speckle tracking technology to measure
Time frame
From enrollment to the end of treatment at 12 months2
conduit phase (LAScd)
Using three-dimensional speckle tracking technology to measure
Time frame
From enrollment to the end of treatment at 12 months3
hospitalization due to heart failure
Record events of subjects visiting or being hospitalized due to heart failure during the follow-up period. This endpoint includes patients who present with symptoms such as dyspnea, fatigue, and orthopnea during the follow-up period, and have an NT-proBNP level greater than 300pg/ml detected in the emergency department, outpatient clinic, or inpatient department, with a documented diagnosis.
Time frame
From enrollment to the end of treatment at 12 months4
changes in blood pressure
Patients undergo standardized office blood pressure monitoring (OBPM) using automated oscillometric devices or manual sphygmomanometry with appropriate cuff sizes. Measurements are obtained after 5 minutes of seated rest, with feet flat on the floor and arm supported at heart level. Two to three readings are taken 1-2 minutes apart, and the average is recorded. Take the blood pressure test for every month. Ensure that the medication use of the enrolled subjects remains unchanged during the follow-up period.
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Huashan Hospital
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
Shanghai 10th People's Hospital
Collaborator
Source ClinicalTrials.gov