The Effect of Correction of Bacterial Overgrowth Syndrome in the Small Intestine on Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
Moscow
RECRUITING
Moscow
Contact Information
Primary
Konstantin Ivashkin
ivashkin_k_v@staff.sechenov.ru
+7 926 213 58 33
Backup
Elena Bueverova
bueverova_e_l@staff.sechenov.ru
+7 916 526 6245
Time Frame
Start Date: 2024-09-02
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 40
Treatments
Experimental: intervention group
Patients of the experimental group will receive standart therapy HFpEF and rifaximin (Alfa Normix®, Alfa Wassermann S.P.A., Italy, registration number LS-001993, 08/31/2010) at a dose of 200 mg 3 times a day for 7 days.
Active_comparator: control group
Patients of the control group will receive standart therapy HFpEF Without Rifaximin
Sponsors
Leads: I.M. Sechenov First Moscow State Medical University

This content was sourced from clinicaltrials.gov