RecruitingNot Applicable

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

Russia40 participantsStarted 2024-09-02

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.)

What they're measuring

Changing the functional class (FC) of chronic heart failure (CHF)

Timeframe: Day 1, day 10, day 40

Change in clinical condition

Timeframe: Day 1, day 40

Trial details

NCT IDNCT06652087

SponsorI.M. Sechenov First Moscow State Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Konstantin Ivashkin

+7 926 213 58 33 ivashkin_k_v@staff.sechenov.ru

View on ClinicalTrials.gov More Bacterial Overgrowth Syndrome Small Bowel trials