EMPAGUM: Effects of Empagliflozin on Gut Microbiota in Heart Failure With a Preserved Ejection Fraction
NCT05584319 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2022-12-23
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 HFpEF taking Empagliflozin and explore the role of gut microbiota in this process.
Conditions
Interventions
- DRUG
-
Empagliflozin 10 Mg
subjects in Empagliflozin group takes Empagliflozin 10mg per day
Sponsors & Collaborators
-
Zhijun Sun
lead OTHER
Principal Investigators
-
10027 10027 · Shengjing Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-15
- Primary Completion
- 2024-10-31
- Completion
- 2025-10-31
Countries
- China
Study Locations
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