Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction
Recruiting · NCT06652087 · Interventional (participants receive a specific treatment) · Lead sponsor: I.M. Sechenov First Moscow State Medical University
View the official record on ClinicalTrials.gov →Interventions studied
RifaximinStandard HFpEF treatment
What this trial is about
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 take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.)
Where it is running
1 location listed.
- Moscow - Moscow, Russia