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

NCT05584319 | Unknown Phase 4

• 1 other identifier: 2022PS999K
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Heart Failure With Preserved Ejection Fraction

Keywords

Heart Failure; Gut Microbiota; SGLT2 Inhibitor; Myocardial Fibrosis; Short-chain Fatty Acids; Derived Metabolite

Outcome Measures

Primary Outcomes (1)

• intestinal microbiota diversity

  the changes of Alpha diversity and Beta diversity of intestinal microbiota in samples

  6 months

Secondary Outcomes (4)

• Major Adverse Cardiovascular Events (MACE)

  6 months

• N-terminal prohormone of B-type natriuretic peptide ( NT-proBNP )

  6 months

• soluble suppression of tumorigenicity 2 (sST2）

  6 months

• serum SCFAs level

  6 months

Study Arms (2)

Empagliflozin group

EXPERIMENTAL

Subjects in Empagliflozin group take in 10Mg Empagliflozin per day.

Drug: Empagliflozin 10 Mg

Blank control group

NO INTERVENTION

Subjects in Blank control group will not receive Empagliflozin or other sglt-2 inhibitors.

Interventions

Empagliflozin 10 Mg DRUG

subjects in Empagliflozin group takes Empagliflozin 10mg per day

Also known as: Empagliflozin

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, BMI 18.5-27.9kg/m.
• Patients with heart failure and EF\>40%, New York Heart Association classification ( NYHA) class II-IV and evidence of structural heart disease (i.e. left ventricular hypertrophy or left atrial enlargement by the recent echocardiogram within the last 12 months before enrollment).
• NT-proBNP≥300 pg/ml for patients without AF, or ≥600 pg/ml for patients with atrial fibrillation (AF).
• Signed and dated written informed consent form (ICF)

You may not qualify if:

• 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.
• 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).
• Combination of sever infectious diseases (e.g. Severe myocarditis, severe pneumonia, and severe urinary tract infection ).
• Acute decompensated heart failure. 9.Severe diseases in other systems (e.g. severe liver insufficiency, moderate-severe anemia, malignant tumors, hematological diseases).
• Known or suspected allergy to the active or inactive ingredients of the drug under study.
• Admitted percutaneous coronary intervention (PCI), or cardiac surgery, cardiac resynchronization (CRT), or other surgery within the past 90 days.
• 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.
• 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.

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 Officials

• 10027 10027

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

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 8, 2022
• First Posted: October 18, 2022
• Study Start: December 15, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)