Atrial Fibrillation (AF)Phase 2NCT07482020
SGLT2i Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation, Hypertension and Abnormal Glucose Metabolism
A Phase 2 study testing SGLT-2 inhibitors in people with Atrial Fibrillation (AF) and Hypertension, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF), Hypertension
- What is being tested?
- SGLT-2 inhibitors
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Jun 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
- Patients with a history of myocardial infarction within the past three months.
- Pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Affiliated Huashan Hospital, Cardiology Department
Shanghai, Shanghai Municipality, 200036
Liwen Bao, MD, 86 13917073226, blw_betty@163.com
About this study
Official title: A Randomized Controlled Trial of SGLT2 Inhibitors to Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation and Comorbid Hypertension and Abnormal Glucose Metabolism
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.
Read the detailed description
- Research Methods: This study adopts a multicenter, randomized, placebo-controlled approach, utilizing three-dimensional speckle tracking technology to evaluate the left atrial function of enrolled subjects.
- Research Objectives: Compared with placebo, to observe whether empagliflozin (10mg qd) can improve the left atrial function of patients with paroxysmal atrial fibrillation (AF) who have hypertension and metabolic disorders.
- Research Endpoints:
- Primary Endpoint: Using three-dimensional speckle tracking technology to evaluate the changes in left atrial function of subjects in the empagliflozin group and the placebo group at enrollment and after 12 months of follow-up.
- Evaluation Methods for Primary Endpoint: The left atrial function evaluation of all subjects from all centers will be completed in the echocardiography room of Huashan Hospital. This examination will be conducted in a blinded manner by two experienced echocardiography physicians to assess the left atrial function of the patients, and another two echocardiography physicians will analyze the parameters in a blinded manner.
- Parameters of Left Atrial Function Changes: Left atrial ejection fraction, left atrial ejection volume, left atrial maximum volume, left atrial minimum volume, left atrial pre-systolic volume, left atrial maximum volume index, peak left atrial longitudinal strain, early diastolic left atrial longitudinal strain, late diastolic left atrial longitudinal strain, peak left atrial circumferential strain, early diastolic left atrial circumferential strain, and late diastolic left atrial circumferential strain.
- Secondary Endpoint 1: 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.
- Secondary Endpoint 2: Record the changes in cardiovascular and metabolic risk factors of patients at enrollment and after 12 months of follow-up: blood pressure, blood glucose, uric acid, body weight, and blood lipids. Ensure that the medication use of the enrolled subjects remains unchanged during the follow-up period.
- Randomization and Blinding Arrangements: Use random numbers to randomize the enrolled patients into groups; blind two echocardiography physicians who assess the left atrial function of the subjects and two echocardiography physicians who analyze the left atrial function parameters; blind the subjects; and blind the researchers.
- Follow-up Medication Use:
- Experimental Drug: Dapagliflozin 10mg qd, to be used continuously for 12 months.
- Placebo Drug: A placebo with the same specifications, odor, and color as dapagliflozin, to be used continuously for 12 months.
- Follow-up Duration: 12 months. At enrollment and at the 12th month of follow-up, use three-dimensional speckle tracking technology to complete the left atrial function (evaluated in sinus rhythm) examination of the subjects, and complete the biochemical examinations of blood pressure, blood glucose, blood lipids, body weight, uric acid, etc. Record events of subjects visiting or being hospitalized due to heart failure during the follow-up period.
- Inclusion Criteria:
- 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.
- Exclusion Criteria:
- 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.
- Patients with a history of myocardial infarction within the past three months.
- Pregnant women.
- Withdrawal Criteria:
- Patients who cannot undergo echocardiography according to the follow-up schedule after enrollment.
- Patients who cannot take medication on time after enrollment.
- Subjects who are unwilling or unable to continue participating in the trial.
- Subjects who are found to be ineligible for enrollment or meet any exclusion criteria after enrollment.
- Subjects who experience intolerable adverse events or serious adverse events, and the researcher determines that the risks of continuing to participate in the trial outweigh the benefits for the subject.
- Subjects who are lost to follow-up.
- Sample Size Calculation: Since there are no previous data on the application of SGLT2i in patients with paroxysmal AF, based on the investigators' preliminary experimental results, the difference in left atrial function between patients with paroxysmal AF and healthy patients is as follows: left atrial reservoir function longitudinal strain, 16.1±5.41 in the paroxysmal AF group vs. 20.5±6.55 in the healthy control group. Referring to this parameter, with a power of 0.8 and α of 0.05, the sample size for this study is calculated using statistical formulas as: N=60, with N=30 in each group. Considering a 10% dropout rate, the total number of cases is N=66, with N=33 in each group.
- Research Process: Applicable to all centers
- Introduce the study to patients who meet the above criteria, and those who agree to join will sign the informed consent form.
- After obtaining informed consent, generate random numbers for randomization into groups.
- After determining the groups, before administering the medication, complete the baseline left atrial function examination and the examination of cardiovascular and metabolic risk factors, including blood pressure, blood glucose, blood lipids, uric acid, body weight, etc.
- Administer medication according to the randomized groups.
- Conduct a telephone follow-up with patients once a month to record medication use, occurrence of heart failure events, and occurrence of adverse events.
- At the 12th month, conduct another evaluation of left atrial function and examination of cardiovascular and metabolic risk factors.
- Measurement Methods and Techniques for the Main Observation Indicators in This Study
- To avoid measurement bias in the study, all echocardiography examinations of subjects enrolled in all centers will be completed in the echocardiography room of the main hospital of Huashan Hospital.
- Two experienced echocardiography physicians will collect left atrial data from patients, and another two echocardiography physicians will perform statistical analysis of the data on an offline analysis workstation. All four echocardiography physicians will be blinded.
- Left Atrial Structure and Function: Firstly, two experienced echocardiography physicians will use the Vivid E95 machine equipped with probes of frequencies M5S 3.5-5MHz and Vivid7 3V 2-4MHz (GE Vingmed Ultrasound, Horten, Norway) to collect three-dimensional speckle images from the enrolled subjects in a blinded manner. All collected images will be imported into the dedicated offline analysis workstation provided by the manufacturer (EchoPAC version 2.0; GE Vingmed Ultrasound), and two echocardiography physicians will perform four-dimensional automatic left atrial quantification (4D Auto LAQ) analysis in a blinded manner.
- Left Ventricular Parameters: Simultaneously, collect left ventricular parameters including left ventricular end-systolic volume, left ventricular end-diastolic diameter, LVEF assessed by Simpson's method, and E wave, A wave, E/A ratio, or E/e' assessed by pulsed Doppler or tissue Doppler.
- Assessment of Heart Failure Occurrence: Record events of subjects visiting the outpatient clinic, emergency department, 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, and are diagnosed with heart failure with a documented diagnosis.
- Collection of Cardiovascular and Metabolic Abnormality Parameters: At enrollment and after 12 months of follow-up, collect body weight, height, waist circumference, systolic blood pressure, diastolic blood pressure, heart rate, 24-hour ambulatory blood pressure, fasting blood glucose, insulin, C-peptide
- Conditions
- Atrial Fibrillation (AF), Hypertension
- Being tested
- SGLT-2 inhibitors, Placebo
- Keywords
- SGLT2 inhibitor, atrial fibrillation, hypertension
- Medical subject headings
- Atrial Fibrillation, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorsDrug
empagliflozin (10mg qd)
PlaceboDrug
PLACEBO
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 i TREATMENT | Active comparator | Not described Receives: Drug: SGLT-2 inhibitors |
| PLACEBO | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrollment to the end of treatment at 12 months
Secondary outcomes (6)
circumferential strain (LASr-c)
Using three-dimensional speckle tracking technology to measure
Measured: From enrollment to the end of treatment at 12 months
conduit phase (LAScd)
Using three-dimensional speckle tracking technology to measure
Measured: From enrollment to the end of treatment at 12 months
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.
Measured: From enrollment to the end of treatment at 12 months
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.
Measured: From enrollment to the end of treatment at 12 months
change in blood glucose
Patients undergo venous blood sampling after 8-12 hours of overnight fasting. Measurements are performed using standardized enzymatic methods (hexokinase or glucose oxidase). HbA1c is measured via high-performance liquid chromatography (HPLC) or immunoassay. FPG monthly; HbA1c every 3 months. Ensure that the medication use of the enrolled subjects remains unchanged during the follow-up period.
Measured: From enrollment to the end of treatment at 12 months
Change in lipid metabolism
Fasting venous blood sampling (12-14 hours overnight fast) followed by Enzymatic colorimetric assays for TC, TG, and HDL-C. Testing is done every month. Ensure that the medication use of the enrolled subjects remains unchanged during the follow-up period.
Measured: from enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start1 Mar 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai 10th People's Hospital
- Responsible party
- Principal investigator, Yong Li, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07482020
- Sponsor's protocol ID
- SGLT2i in AF
- Status last verified
- Mar 2026
- First submitted
- 7 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of SGLT2 Inhibitors to Improve Left Atrial Function in Patients With Paroxysmal Atrial Fibrillation and Comorbid Hypertension and Abnormal Glucose Metabolism
- ClinicalTrials.gov ID
- NCT07482020
- Acronym / sponsor ID
- SGLT2i in AF
- Conditions
- Atrial Fibrillation (AF), Hypertension
- Keywords
- SGLT2 inhibitor, atrial fibrillation, hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Zhongshan Hospital, Shanghai 10th People's Hospital
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Research Methods: This study adopts a multicenter, randomized, placebo-controlled approach, utilizing three-dimensional speckle tracking technology to evaluate the left atrial function of enrolled subjects.
- Research Objectives: Compared with placebo, to observe whether empagliflozin (10mg qd) can improve the left atrial function of patients with paroxysmal atrial fibrillation (AF) who have hypertension and metabolic disorders.
- Research Endpoints:
- Primary Endpoint: Using three-dimensional speckle tracking technology to evaluate the changes in left atrial function of subjects in the empagliflozin group and the placebo group at enrollment and after 12 months of follow-up.
- Evaluation Methods for Primary Endpoint: The left atrial function evaluation of all subjects from all centers will be completed in the echocardiography room of Huashan Hospital. This examination will be conducted in a blinded manner by two experienced echocardiography physicians to assess the left atrial function of the patients, and another two echocardiography physicians will analyze the parameters in a blinded manner.
- Parameters of Left Atrial Function Changes: Left atrial ejection fraction, left atrial ejection volume, left atrial maximum volume, left atrial minimum volume, left atrial pre-systolic volume, left atrial maximum volume index, peak left atrial longitudinal strain, early diastolic left atrial longitudinal strain, late diastolic left atrial longitudinal strain, peak left atrial circumferential strain, early diastolic left atrial circumferential strain, and late diastolic left atrial circumferential strain.
- Secondary Endpoint 1: 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.
- Secondary Endpoint 2: Record the changes in cardiovascular and metabolic risk factors of patients at enrollment and after 12 months of follow-up: blood pressure, blood glucose, uric acid, body weight, and blood lipids. Ensure that the medication use of the enrolled subjects remains unchanged during the follow-up period.
- Randomization and Blinding Arrangements: Use random numbers to randomize the enrolled patients into groups; blind two echocardiography physicians who assess the left atrial function of the subjects and two echocardiography physicians who analyze the left atrial function parameters; blind the subjects; and blind the researchers.
- Follow-up Medication Use:
- Experimental Drug: Dapagliflozin 10mg qd, to be used continuously for 12 months.
- Placebo Drug: A placebo with the same specifications, odor, and color as dapagliflozin, to be used continuously for 12 months.
- Follow-up Duration: 12 months. At enrollment and at the 12th month of follow-up, use three-dimensional speckle tracking technology to complete the left atrial function (evaluated in sinus rhythm) examination of the subjects, and complete the biochemical examinations of blood pressure, blood glucose, blood lipids, body weight, uric acid, etc. Record events of subjects visiting or being hospitalized due to heart failure during the follow-up period.
- Inclusion Criteria:
- 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.
- Exclusion Criteria:
- 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.
- Patients with a history of myocardial infarction within the past three months.
- Pregnant women.
- Withdrawal Criteria:
- Patients who cannot undergo echocardiography according to the follow-up schedule after enrollment.
- Patients who cannot take medication on time after enrollment.
- Subjects who are unwilling or unable to continue participating in the trial.
- Subjects who are found to be ineligible for enrollment or meet any exclusion criteria after enrollment.
- Subjects who experience intolerable adverse events or serious adverse events, and the researcher determines that the risks of continuing to participate in the trial outweigh the benefits for the subject.
- Subjects who are lost to follow-up.
- Sample Size Calculation: Since there are no previous data on the application of SGLT2i in patients with paroxysmal AF, based on the investigators' preliminary experimental results, the difference in left atrial function between patients with paroxysmal AF and healthy patients is as follows: left atrial reservoir function longitudinal strain, 16.1±5.41 in the paroxysmal AF group vs. 20.5±6.55 in the healthy control group. Referring to this parameter, with a power of 0.8 and α of 0.05, the sample size for this study is calculated using statistical formulas as: N=60, with N=30 in each group. Considering a 10% dropout rate, the total number of cases is N=66, with N=33 in each group.
- Research Process: Applicable to all centers
- Introduce the study to patients who meet the above criteria, and those who agree to join will sign the informed consent form.
- After obtaining informed consent, generate random numbers for randomization into groups.
- After determining the groups, before administering the medication, complete the baseline left atrial function examination and the examination of cardiovascular and metabolic risk factors, including blood pressure, blood glucose, blood lipids, uric acid, body weight, etc.
- Administer medication according to the randomized groups.
- Conduct a telephone follow-up with patients once a month to record medication use, occurrence of heart failure events, and occurrence of adverse events.
- At the 12th month, conduct another evaluation of left atrial function and examination of cardiovascular and metabolic risk factors.
- Measurement Methods and Techniques for the Main Observation Indicators in This Study
- To avoid measurement bias in the study, all echocardiography examinations of subjects enrolled in all centers will be completed in the echocardiography room of the main hospital of Huashan Hospital.
- Two experienced echocardiography physicians will collect left atrial data from patients, and another two echocardiography physicians will perform statistical analysis of the data on an offline analysis workstation. All four echocardiography physicians will be blinded.
- Left Atrial Structure and Function: Firstly, two experienced echocardiography physicians will use the Vivid E95 machine equipped with probes of frequencies M5S 3.5-5MHz and Vivid7 3V 2-4MHz (GE Vingmed Ultrasound, Horten, Norway) to collect three-dimensional speckle images from the enrolled subjects in a blinded manner. All collected images will be imported into the dedicated offline analysis workstation provided by the manufacturer (EchoPAC version 2.0; GE Vingmed Ultrasound), and two echocardiography physicians will perform four-dimensional automatic left atrial quantification (4D Auto LAQ) analysis in a blinded manner.
- Left Ventricular Parameters: Simultaneously, collect left ventricular parameters including left ventricular end-systolic volume, left ventricular end-diastolic diameter, LVEF assessed by Simpson's method, and E wave, A wave, E/A ratio, or E/e' assessed by pulsed Doppler or tissue Doppler.
- Assessment of Heart Failure Occurrence: Record events of subjects visiting the outpatient clinic, emergency department, 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, and are diagnosed with heart failure with a documented diagnosis.
- Collection of Cardiovascular and Metabolic Abnormality Parameters: At enrollment and after 12 months of follow-up, collect body weight, height, waist circumference, systolic blood pressure, diastolic blood pressure, heart rate, 24-hour ambulatory blood pressure, fasting blood glucose, insulin, C-peptide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 i TREATMENT | Active comparator | Drug: SGLT-2 inhibitors |
| PLACEBO | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patients aged 18-80 years, treated in the outpatient or inpatient departments of each research center and included in the AF database.
Key exclusion criteria (6 listed)
- • Atrial fibrillation caused by severe mitral stenosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT-2 inhibitorsempagliflozin (10mg qd) | Drug | SGLT2 i TREATMENT |
| PlaceboPLACEBO | Drug | PLACEBO |
Primary outcome
LA strain （LASI）
Time frame: from enrollment to the end of treatment at 12 months
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.
6 secondary outcomes
circumferential strain (LASr-c)
Time frame: From enrollment to the end of treatment at 12 months
conduit phase (LAScd)
Time frame: From enrollment to the end of treatment at 12 months
hospitalization due to heart failure
Time frame: From enrollment to the end of treatment at 12 months
changes in blood pressure
Time frame: From enrollment to the end of treatment at 12 months
change in blood glucose
Time frame: From enrollment to the end of treatment at 12 months
Change in lipid metabolism
Time frame: from enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGLT-2 inhibitors in people with Atrial Fibrillation (AF) and Hypertension, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liwen Bao, MD (86 13917073226, blw_betty@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LA strain （LASI） (time frame: from enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.