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

NCT05600387 | Unknown Phase 4

• 1 other identifier: 2022PS1015K
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Heart Failure; Empagliflozin; Function of left atrium

Outcome Measures

Primary Outcomes (3)

• change of peak atrial longitudinal strain during 6 months

  peak atrial longitudinal strain will be assessed using echocardiography

  6 months

• change of peak atrial contraction strain during 6 months

  peak atrial contraction strain will be assessed using echocardiography

  6 months

• change of left atrial conduit strain during 6 months

  left atrial conduit strain will be assessed using echocardiography

  6 months

Secondary Outcomes (14)

• change of left atrial volume index during 6 months

  6 months

• change of E/A during 6 months

  6 months

• change of E/e'during 6 months

  6 months

• change of left ventricular global longitudinal strain during 6 months

  6 months

• change of left ventricular ejection fraction during 6 months

  6 months

Study Arms (2)

Empagliflozin group

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG

Control group

NO INTERVENTION

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

Interventions

Empagliflozin 10 MG DRUG

subjects in Empagliflozin group take 10mg Empagliflozin per day

Empagliflozin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhijun Sun: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the second Department of cardiovascular medicine

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 31, 2022
• Study Start: November 5, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: March 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)