EMPAGUM: Effects of Empagliflozin on Gut Microbiota in Heart Failure With a Preserved Ejection Fraction

Sponsor
Zhijun Sun
Study ID
NCT05584319
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 15, 2022
Status verified
Dec 2022
Primary completion
Oct 31, 2024
Completion
Oct 31, 2025

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Empagliflozin group
    Subjects in Empagliflozin group take in 10Mg Empagliflozin per day.
  • No Intervention: Blank control group
    Subjects in Blank control group will not receive Empagliflozin or other sglt-2 inhibitors.

Primary Outcome Measure

intestinal microbiota diversity [ Time Frame: 6 months ]

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