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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorI.M. Sechenov First Moscow State Medical University

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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.)

Trial design

Treatments tested in this trial

  • Rifaximin
  • Standard HFpEF treatment

Treatment groups

40 Participants
are divided into 2 treatment groups