NCT06652087 Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction
| NCT ID | NCT06652087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | I.M. Sechenov First Moscow State Medical University |
| Condition | Bacterial Overgrowth Syndrome Small Bowel |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-09-02 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.)
Contact & Investigator
Vladimir Ivashkin
PRINCIPAL INVESTIGATOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Frequently Asked Questions
Who can join the NCT06652087 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Bacterial Overgrowth Syndrome Small Bowel. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06652087 currently recruiting?
Yes, NCT06652087 is actively recruiting participants. Contact the research team at ivashkin_k_v@staff.sechenov.ru for enrollment information.
Where is the NCT06652087 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT06652087 clinical trial?
NCT06652087 is sponsored by I.M. Sechenov First Moscow State Medical University. The principal investigator is Vladimir Ivashkin at I.M. Sechenov First Moscow State Medical University (Sechenov University). The trial plans to enroll 40 participants.