RecruitingNot ApplicableNCT06652087

Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction

The Effect of Correction of Bacterial Overgrowth Syndrome in the Small Intestine on Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction

Sponsor

I.M. Sechenov First Moscow State Medical University

Enrollment

40 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction Bacterial Overgrowth Syndrome Small Bowel

Summary

Single-center, double-blind, randomized, controlled intervention study of the effect of correction of bacterial overgrowth syndrome in the small intestine (SIBO) on cardiac function in patients with heart failure with preserved ejection fraction (HFpEF) (SIBO-HFpEF). The aim of the study is to evaluate the efficacy and safety of rifaximin in patients with HFpEF and SIBO.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

availability of written informed consent of the patient to participate in the study
adult aged ≥18≤80 years' old
body mass index ≥25 kg/m2
diagnosed with HFpEF: 1) symptoms and/or signs of heart failure; 2) left ventricular ejection fraction ≥50%; 3) increased levels of natriuretic peptides (NTproBNP≥125 pg/mL); 4) at least one additional criterion: relevant structural heart disease (hypertrophy of the left ventricle (LVH) and/or enlargement of the left atrium (LAE) or diastolic dysfunction

Exclusion Criteria2

refusal of the patient from further participation in the study
identification of any disease or condition specified in the criteria for non-inclusion and the development of a severe pathological condition in which patient monitoring becomes poorly implemented and the presence of which may make it difficult to interpret the data (gastrointestinal bleeding, myocardial infarction, etc.)

Interventions

DRUGRifaximin

Rifaximin (Alfa Normix®, Alfa Wassermann S.P.A., Italy, registration number LS-001993, 08/31/2010) in standard doses of 200 mg 3 times a day for 7 days

OTHERStandard HFpEF treatment

diuretic, including an aldosterone antagonist; sodium-glucose cotransporter-2 inhibitor