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Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

Primary Purpose

Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction

Status
Enrolling by invitation
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Empagliflozin 10 MG
Sponsored by
Zhijun Sun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Empagliflozin, Function of left atrium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years old, BMI18.5-27.9kg/m² Meet the definition of chronic heart failure and an ejection fraction of 40% or more (according to 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure) Elevated NT-proBNP levels of more than 300 pg/mL Signed and dated written informed consent form Exclusion Criteria: Myocardial infarction,coronary artery bypass graft surgery, or other major cardiovascular surgery within 30 days after enrollment Percutaneous coronary intervention ,coronary artery bypass graft surgery,cardiac resynchronization therapy, implantable cardioverter defibrillatoror or other cardiac surgeries within 90 days prior to enrollment Atrial fibrillation or flutter SGLT-2i using within 90 days prior to enrollment Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease),cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction Acute decompensated heart failure. Moderate to severe valvular stenosis or regurgitation Symptomatic hypotension with systolic pressure ≤ 90mmHg or uncontrolled hypertension using drugs with systolic blood pressure of ≥180 mmHg at randomization Sever infectious diseases(e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection) Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy or hospitalization for exacerbation within 12 months Other significant co-morbid conditions(impaired renal function( an estimated glomerular filtration rate of <20 mL/min/1.73 m2), hepatic failure, malignant tumors, severe hematologic diseases, etc.) Major surgery performed within 90 days prior to enrollment or major scheduled elective surgery within 90 days after enrollment(major according to the investigator's assessment,such as gastrointestinal surgery that might interfere with trial medication absorption or malignant tumors surgery) Type 1 diabetes or history of ketoacidosis Pregnancy Completion within 90 days of a trial of another drug study. Receipt of any investigative treatment other than the study medications for this trial

Sites / Locations

  • Shengjing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Empagliflozin group

Control group

Arm Description

subjects in Empagliflozin group take 10mg Empagliflozin 10mg per day

subjects in Control group will not receive Empagliflozin or other sglt-2 inhibitors

Outcomes

Primary Outcome Measures

change of peak atrial longitudinal strain during 6 months
peak atrial longitudinal strain will be assessed using echocardiography
change of peak atrial contraction strain during 6 months
peak atrial contraction strain will be assessed using echocardiography
change of left atrial conduit strain during 6 months
left atrial conduit strain will be assessed using echocardiography

Secondary Outcome Measures

change of left atrial volume index during 6 months
left atrial volume index will be assessed using echocardiography
change of E/A during 6 months
E/A will be assessed using echocardiography,and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity
change of E/e'during 6 months
E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity
change of left ventricular global longitudinal strain during 6 months
left ventricular global longitudinal strain will be assessed using echocardiography
change of left ventricular ejection fraction during 6 months
left ventricular ejection fraction will be assessed using echocardiography
peak atrial longitudinal strain in the sixth month
peak atrial longitudinal strain will be assessed using echocardiography
peak atrial contraction strain in the sixth month
peak atrial contraction strain will be assessed using echocardiography
left atrial conduit strain in the sixth month
left atrial conduit strain will be assessed using echocardiography
left atrial volume index in the sixth month
left atrial volume index will be assessed using echocardiography
E/A in the sixth month
E/A will be assessed using echocardiography,and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity
E/e' in the sixth month
E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity
left ventricular global longitudinal strain in the sixth month
left ventricular global longitudinal strain will be assessed using echocardiography
left ventricular ejection fraction in the sixth month
left ventricular ejection fraction will be assessed using echocardiography
new-onset atrial fibrillation in the sixth month
new-onset atrial fibrillation is defined as follows:no atrial fibrillation at screening and electrocardiogram in the sixth month indicates atrial fibrillation

Full Information

First Posted
October 21, 2022
Last Updated
March 5, 2023
Sponsor
Zhijun Sun
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1. Study Identification

Unique Protocol Identification Number
NCT05600387
Brief Title
Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Official Title
Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 5, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhijun Sun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The number of heart failure with mildly reduced or preserved ejection fraction gradually increases. SGLT2-i has been shown to reduce the risk of hospitalization for heart failure and cardiovascular death among patients with chronic heart failure and a left ventricular ejection fraction of 40% or more . However,its effect on the function on left atrium in heart failure with mildly reduced or preserved ejection fraction is still unknown.
Detailed Description
Heart failure with mildly reduced or preserved ejection fraction has become an important part of heart failure, the proportion is also gradually increased .Atrial fibrillation , as a common arrhythmia disease, is often caused by heart failure and aggravates the process of heart failure. It has been documented that in patients with heart failure and an ejection fraction more than 40%, it may have a higher incidence of atrial fibrillation.Heart failure and atrial fibrillation together increase the risk of stroke, hospitalization for heart failure, and all-cause death from heart failure. SGLT-2 inhibitor (SGLT-2i) is a new metabolic drug, through a variety of mechanisms on cardiac metabolism, has been shown to reduce the risk of death and rehospitalization, and improve the health of patients with heart failure.But the effect on preventing arrhythmia in patients with heart failure is still unclear. Some studies have shown that SGLT-2i reduces the left atrial volume index and the left ventricular diastolic volume index compared with placebo and some have proved that the indicators of the function of left atrium, such as peak atrial longitudinal strain (PALS), peak atrial contraction strain (PACS), can effectively predict the occurrence of atrial fibrillation. The purpose of this study is to apply empagliflozin (a class of SGLT-2i) in heart failure patients with mildly reduced or preserved ejection fraction to measure the changes in the function of left atrium and thus verify its prevention and control effect on atrial fibrillation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Keywords
Heart Failure, Empagliflozin, Function of left atrium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin group
Arm Type
Experimental
Arm Description
subjects in Empagliflozin group take 10mg Empagliflozin 10mg per day
Arm Title
Control group
Arm Type
No Intervention
Arm Description
subjects in Control group will not receive Empagliflozin or other sglt-2 inhibitors
Intervention Type
Drug
Intervention Name(s)
Empagliflozin 10 MG
Intervention Description
subjects in Empagliflozin group take 10mg Empagliflozin per day
Primary Outcome Measure Information:
Title
change of peak atrial longitudinal strain during 6 months
Description
peak atrial longitudinal strain will be assessed using echocardiography
Time Frame
6 months
Title
change of peak atrial contraction strain during 6 months
Description
peak atrial contraction strain will be assessed using echocardiography
Time Frame
6 months
Title
change of left atrial conduit strain during 6 months
Description
left atrial conduit strain will be assessed using echocardiography
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change of left atrial volume index during 6 months
Description
left atrial volume index will be assessed using echocardiography
Time Frame
6 months
Title
change of E/A during 6 months
Description
E/A will be assessed using echocardiography,and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity
Time Frame
6 months
Title
change of E/e'during 6 months
Description
E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity
Time Frame
6 months
Title
change of left ventricular global longitudinal strain during 6 months
Description
left ventricular global longitudinal strain will be assessed using echocardiography
Time Frame
6 months
Title
change of left ventricular ejection fraction during 6 months
Description
left ventricular ejection fraction will be assessed using echocardiography
Time Frame
6 months
Title
peak atrial longitudinal strain in the sixth month
Description
peak atrial longitudinal strain will be assessed using echocardiography
Time Frame
6 months
Title
peak atrial contraction strain in the sixth month
Description
peak atrial contraction strain will be assessed using echocardiography
Time Frame
6 months
Title
left atrial conduit strain in the sixth month
Description
left atrial conduit strain will be assessed using echocardiography
Time Frame
6 months
Title
left atrial volume index in the sixth month
Description
left atrial volume index will be assessed using echocardiography
Time Frame
6 months
Title
E/A in the sixth month
Description
E/A will be assessed using echocardiography,and it is defined as the ratio of peak early diastolic flow velocity and peak late diastolic flow velocity
Time Frame
6 months
Title
E/e' in the sixth month
Description
E/e' will be assessed using echocardiography and it is defined as the ratio of peak early diastolic flow velocity and peak early diastolic mitral annular velocity
Time Frame
6 months
Title
left ventricular global longitudinal strain in the sixth month
Description
left ventricular global longitudinal strain will be assessed using echocardiography
Time Frame
6 months
Title
left ventricular ejection fraction in the sixth month
Description
left ventricular ejection fraction will be assessed using echocardiography
Time Frame
6 months
Title
new-onset atrial fibrillation in the sixth month
Description
new-onset atrial fibrillation is defined as follows:no atrial fibrillation at screening and electrocardiogram in the sixth month indicates atrial fibrillation
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old, BMI18.5-27.9kg/m² Meet the definition of chronic heart failure and an ejection fraction of 40% or more (according to 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure) Elevated NT-proBNP levels of more than 300 pg/mL Signed and dated written informed consent form Exclusion Criteria: Myocardial infarction,coronary artery bypass graft surgery, or other major cardiovascular surgery within 30 days after enrollment Percutaneous coronary intervention ,coronary artery bypass graft surgery,cardiac resynchronization therapy, implantable cardioverter defibrillatoror or other cardiac surgeries within 90 days prior to enrollment Atrial fibrillation or flutter SGLT-2i using within 90 days prior to enrollment Cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease),cardiomyopathy with reversible causes (e.g. stress cardiomyopathy), or known pericardial constriction Acute decompensated heart failure. Moderate to severe valvular stenosis or regurgitation Symptomatic hypotension with systolic pressure ≤ 90mmHg or uncontrolled hypertension using drugs with systolic blood pressure of ≥180 mmHg at randomization Sever infectious diseases(e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection) Chronic pulmonary disease requiring home oxygen, oral corticosteroid therapy or hospitalization for exacerbation within 12 months Other significant co-morbid conditions(impaired renal function( an estimated glomerular filtration rate of <20 mL/min/1.73 m2), hepatic failure, malignant tumors, severe hematologic diseases, etc.) Major surgery performed within 90 days prior to enrollment or major scheduled elective surgery within 90 days after enrollment(major according to the investigator's assessment,such as gastrointestinal surgery that might interfere with trial medication absorption or malignant tumors surgery) Type 1 diabetes or history of ketoacidosis Pregnancy Completion within 90 days of a trial of another drug study. Receipt of any investigative treatment other than the study medications for this trial
Facility Information:
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Empagliflozin on the Function of Left Atrium in Heart Failure With Mildly Reduced or Preserved Ejection Fraction

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