Effect of Rifaximin on Heart Function in Patients with Heart Failure and Bacterial Overgrowth
Official title: The Effect of Correction of Bacterial Overgrowth Syndrome in the Small Intestine on Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction
Run by I.M. Sechenov First Moscow State Medical University · NCT06652087 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | I.M. Sechenov First Moscow State Medical University Academic / other |
| Locations | 1 site (Moscow) |
| Status | Recruiting |
| Started | September 2, 2024 |
| Main results expected | September 30, 2026 |
| Study ends | September 30, 2027 |
| Registry record updated | October 22, 2024 |
| Trial ID | NCT06652087 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with severe comorbid conditions or those who refuse participation may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote rehabilitation for HFpEF patients using telerehabilitation
A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.
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EDG-15400 in adults with HFpEF: a phase 2 study
This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.
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Incretin therapy with tirzepatide for obesity-related HFpEF
A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.
-
Boosted exercise with group coaching for HFpEF
This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.
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Exercise cardiac MRI for heart failure with preserved ejection fraction
This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.
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HRS-1893 for heart failure with preserved ejection fraction
This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.