Effect of Empagliflozin on Intestinal Microbiota in Patients With Heart Failure (LVEF>40%）

• Status: Not yet recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Empagliflozin was recommended for patients with heart failure with reduced ejection fraction (HFrEF) in 2021 European Society of Cardiology (ESC) guidelines (Class of Recommendation Ia) and patients with heart failure with preserved ejection fraction (HFpEF) in 2022 American Heart Association (AHA) guidelines (Class of Recommendation IIa). However, the physiopathologic mechanisms in its effects on HFpEF are not clear. Studies illustrate that gut microbiota plays an essential role in the progress of the heart failure. Studies on mice found that sodium-glucose cotransporter-2 inhibitors (sglt-2i) could affect the intestinal microbiota in mice. The purpose of this study is to clarify the changes of gut microbiota in the patients with non-reduced ejection fraction taking Empagliflozin and explore the role of gut microbiota in this process.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhijun Sun
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

1. Age ≥ 18 years old

2. Patients with heart failure and EF≧40%, New York Heart Association classification ( NYHA) class II-IV and elevated NT-proBNP > 300 pg/ml for patients without AF, or > 900 pg/ml for patients with atrial fibrillation (AF).

3. Signed and dated written informed consent form (ICF)

Exclusion Criteria:

• 1.Current use or prior use of a sglt-2 inhibitor in 3 months. 2.Patients with type 1 diabetes mellitus. 3.History of ketoacidosis. 4.Impaired renal function with estimated glomerular filtration rate (eGFR)<20ml/min/1.73m².

5.On a diet or with a recent diet plan adjustment. 6.Have gastrointestinal diseases which in active stages (e.g. malabsorptive conditions such as irritable bowel syndrome, coeliac).

7.Combination of sever infectious diseases (e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection ).

8.Acute decompensated heart failure. 9.Severe diseases in other systems (e.g. severe liver insufficiency, moderate-severe anemia, malignant tumors, hematological diseases).

10.Known or suspected allergy to the active or inactive ingredients of the drug under study.

11.Admitted percutaneous coronary intervention (PCI), or cardiac surgery, cardiac resynchronization (CRT), or other surgery within the past 90 days.

12.Arranging to receive cardiovascular revascularization (percutaneous intervention or surgery) or major heart surgery (coronary artery bypass transplantation, valve replacement, ventricular aids, heart transplantation, CRT or any other surgery requiring thoracotomy or transcatheter aortic valve replacement) in 30 days.

13.Symptomatic hypotension with systolic pressure ≤ 90mmHg. 14.Systolic pressure ≥ 180mmHg which cannot be controlled with drugs. 15.Currently enrolled in another investigational device or drug trial. 16.Women who are pregnant, nursing, or who plan to become pregnant while in the trial.