Effect of Rifaximin on Heart Function in Patients with Heart Failure and Bacterial Overgrowth
The Effect of Correction of Bacterial Overgrowth Syndrome in the Small Intestine on Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction
This study is testing if the antibiotic rifaximin can help improve heart function in people with heart failure and bacterial overgrowth in their intestines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Trial ID | NCT06652087 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of rifaximin, an antibiotic, on cardiac function in patients suffering from heart failure with preserved ejection fraction (HFpEF) and small intestinal bacterial overgrowth (SIBO). It is a single-center, double-blind, randomized, controlled intervention where participants will be assigned to either receive rifaximin or standard HFpEF treatment. The study aims to evaluate both the efficacy and safety of rifaximin in improving heart function and addressing the underlying bacterial overgrowth. The trial will include 40 patients with specific eligibility criteria, including a body mass index over 25 kg/m2 and a positive SIBO test.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 80 with HFpEF, a body mass index of 25 kg/m2 or higher, and a confirmed diagnosis of SIBO.
Not a fit: Patients with severe comorbid conditions or those who refuse participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for improving cardiac function in patients with HFpEF and SIBO.
How similar studies have performed: While the role of SIBO in heart failure has been noted, this specific approach using rifaximin in HFpEF patients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. availability of written informed consent of the patient to participate in the study 2. adult aged ≥18≤80 years' old 3. body mass index ≥25 kg/m2 4. 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: 1. refusal of the patient from further participation in the study 2. 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 this trial is running
Moscow
- Moscow — Moscow, Russia (Recruiting)
Study contacts
- Principal investigator: Vladimir Ivashkin — I.M. Sechenov First Moscow State Medical University (Sechenov University)
- Study coordinator: Konstantin Ivashkin
- Email: ivashkin_k_v@staff.sechenov.ru
- Phone: +7 926 213 58 33
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.