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.
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
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.)
Parallel
Rifaximin
DrugRifaximin (Alfa Normix®, Alfa Wassermann S.P.A., Italy, registration number LS-001993, 08/31/2010) in standard doses of 200 mg 3 times a day for 7 days
Standard HFpEF treatment
Other interventiondiuretic, including an aldosterone antagonist; sodium-glucose cotransporter-2 inhibitor
Changing the functional class (FC) of chronic heart failure (CHF)
The 6-Minute Walk Distance (6-MVD) The test will be conducted according to the standard procedure in a marked corridor (length 50 meters) in the morning. Each patient needs to walk the maximum possible distance along the corridor at an acceptably fast pace in 6 minutes. Interpretation of the results in relation to the classification of the New York Heart Association Classification: 426- 550 m corresponds to FC I, 301-425 m corresponds to FC II, 151-300 m corresponds to FC III, less than 150 m corresponds to FC IV.
Change in clinical condition
Clinical Condition Assessment Scale (CCAS) (in the modification of Mareev V.Yu., 2000) This scale includes 10 points (depending on the result, each answer is assigned a certain number of points, which are summed up): shortness of breath (0 - no, 1 - under load, 2 - at rest), weight change over the last week (0 - no, 1 - increased), complaints of irregular heartbeat (0 - no, 1 - there is), the patient's position in bed (0 - horizontally, 1 - with raised headboard (+2 pillows), 2 - plus wakes up from suffocation, 3 - sitting), swollen cervical veins (0 - no, 1 - lying down, 2 - standing), wheezing in the lungs (0 - no, 1 - lower parts (up to 1/3), 2 - up to the shoulder blades (up to 2/3), 3 - over the entire surface of the lungs), the presence of a gallop rhythm (0 - no, 1 - there is), liver (0 - not enlarged, 1 - up to 5 cm, 2 - more than 5 cm), edema (0 - no, 1 - pastosity, 2 - edema, 3 - anasarca), the level of systolic blood pressure (0 - \>120, 1 - 100-200, 2 - \<100 mmHg). Summary
Changes in the level of C-reactive protein in blood serum
Venous blood will be taken on an empty stomach at 7-9 am without any special preparation
Changes in serum fibrinogen levels
Venous blood will be taken on an empty stomach at 7-9 am without any special preparation
Changes in serum ferritin levels
Venous blood will be taken on an empty stomach at 7-9 am without any special preparation
Change in the presence of the small intestinal bacterial overgrowth
Hydrogen breathing test with lactulose on Gastro+ Gastrolyzer (EC60) (Bedfont Scientific Ltd., Great Britain, registration number 2010/06253 dated 09/17/2020) in accordance with the North American consensus: the presence of excessive bacterial growth in the small intestine is considered when the hydrogen content in the breath is increased by at least 20 ppm above the initial value for 90 minutes after taking 10 ml of lactulose dissolved in 200 ml of water
Click on the lead sponsor to view all of their trials.
