An interventional study of Rifaximin and Standard HFpEF treatment in Bacterial Overgrowth Syndrome Small Bowel and Heart Failure with Preserved Ejection Fraction, sponsored by I.M. Sechenov First Moscow State Medical University. Recruiting at 1 site in Russia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by I.M. Sechenov First Moscow State Medical University · Not applicable, Interventional, and Treatment
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.
The proportion of patients with obvious symptoms of chronic heart failure with preserved ejection fraction (HFpEF) is more than 50%, and mortality is comparable to that of patients with low ejection fraction. The lack of evidence regarding therapeutic possibilities for improving the prognosis leads to the search for new treatment regimens. Systemic low-grade inflammation is recognized as the fundamental pathophysiological mechanism of HFpEF. On the one hand, it is caused by obesity, which is the background for the comorbidity of these patients. On the other hand, chronic sluggish systemic inflammation in combination with changes in the composition and metabolic activity of the gut microbiota, dysfunction of the intestinal barrier explains the role of the gut-heart axis in the pathogenesis of HFpEF. There is evidence that small intestinal bacterial overgrowth syndrome (SIBO) is an independent risk factor for re-hospitalization and cardiovascular death among all patients with heart failure. SIBO and its correction in patients with HFpEF have not been sufficiently studied.
Forty patients with HFpEF with a body mass index of more than 25 kg/m2 and a positive SIBO test will be randomly assigned in a ratio of 1:1 to the experimental (rifaximin) and control groups. To detect SIBO, a hydrogen breathing test with lactulose (Duphalac®, Abbott Biologicals B.V., the Netherlands, registration number N011717/02 dated 02/04/2010) will be performed on a medical device "Respiratory hydrogen Gastro+ Gastrolyzer®(EC60) with accessories" (Bedfont Scientific Ltd., Great Britain, registration number 2010/06253 dated 09/17/2020). For 2 hours, every 15 minutes, the patient will be asked to take a deep breath, hold his breath for 10-15 seconds and exhale into a special device for measuring the concentration of hydrogen in the exhaled air. Interpretation of a positive result (threshold of increase from the zero point): ≥20 ppm. Patients in the experimental group (SIBO positive test) will be prescribed rifaximin (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. Patients from the control group (positive SIBO test) will not receive rifaximin. All patients will also receive standard HFpEF treatment (diuretic, including an aldosterone antagonist; sodium-glucose cotransporter-2 inhibitor). Patients will be blinded. A control breath test with lactulose will be performed after completion of rifaximin intake and one month after discharge from the hospital. Markers of systemic inflammation in the blood (levels of C-reactive protein, fibrinogen and ferritin) and parameters of diastolic dysfunction (transthoracic echocardiography) will also be evaluated. After the end of the study, an analysis of the effect of adding rifaximin to the standard treatment of CHF compared with the control group will be carried out.Patients from the control group (with a positive SIBO test result) will not receive rifaximin. All patients will also receive standard treatment for HFRS (diuretics, including an aldosterone antagonist; a sodium-glucose cotransporter-2 inhibitor). Patients will be blinded. A control breath test with lactulose will be performed after completion of rifaximin and one month after discharge from the hospital. Markers of systemic inflammation in the blood (levels of C-reactive protein, fibrinogen and ferritin) and parameters of diastolic dysfunction (transthoracic echocardiography) will also be evaluated. After the end of the study, the effect of adding rifaximin to the standard treatment of CHF will be analyzed compared with the control group. Researchers suggest that rifaximin reduces the level of markers of systemic inflammation, reduces the severity of diastolic dysfunction, is effective in SIBR in patients with HF and BMI≥25 kg/m2, improves their quality of life and prognosis. Patients from the control group (with a positive SIBO test result) will not receive rifaximin. All patients will also receive standard treatment for HFRS (diuretics, including an aldosterone antagonist; a sodium-glucose cotransporter-2 inhibitor). Patients will be blinded. A control breath test with lactulose will be performed after completion of rifaximin and one month after discharge from the hospital. Markers of systemic inflammation in the blood (levels of C-reactive protein, fibrinogen and ferritin) and parameters of diastolic dysfunction (transthoracic echocardiography) will also be evaluated. After the end of the study, the effect of adding rifaximin to the standard treatment of CHF will be analyzed compared with the control group. Researchers suggest that rifaximin reduces the level of markers of systemic inflammation, reduces the severity of diastolic dysfunction, is effective in SIBR in patients with HF and BMI≥25 kg/m2, improves their quality of life and prognosis.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's planned enrollment of 40 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →I.M. Sechenov First Moscow State Medical University is the lead sponsor of 137 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
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.
Drug: Rifaximin · Other: Standard HFpEF treatment
Patients of the control group will receive standart therapy HFpEF Without Rifaximin
Other: Standard HFpEF treatment
Rifaximin (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
Also known as: Alfa Normix®
diuretic, 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.
Time frame: Day 1, day 10, day 40
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
Time frame: Day 1, day 40
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
Time frame: Day 1, day 40
Changes in serum fibrinogen levels
Venous blood will be taken on an empty stomach at 7-9 am without any special preparation
Time frame: Day 1, day 40
Changes in serum ferritin levels
Venous blood will be taken on an empty stomach at 7-9 am without any special preparation
Time frame: Day 1, day 40
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
Time frame: Day 2, day 10, day 40
Change in the maximum volume of the left atrium indexed to the body surface area
Transthoracic echocardiography (GE VIVID E95, "GE Vingmed Ultrasound AS", Norway, registration certificate 2016/3871 dated 10/17/2022) will be performed at 10-12 am without any special preparation
Time frame: Day 1, day 40
Change in the ratio of the maximum rates of early diastolic transmittal blood flow (E) and diastolic elevation of the base of the left ventricle in the early diastole (e') Е/e'
Transthoracic echocardiography (GE VIVID E95, "GE Vingmed Ultrasound AS", Norway, registration certificate 2016/3871 dated 10/17/2022) will be performed at 10-12 am without any special preparation
Time frame: Day 1, day 40
Change in tricuspid regurgitation
Transthoracic echocardiography (GE VIVID E95, "GE Vingmed Ultrasound AS", Norway, registration certificate 2016/3871 dated 10/17/2022) will be performed at 10-12 am without any special preparation
Time frame: Day 1, day 40
Plan to share: No — The disclosure of data is not allowed by the Local Ethics Committee of the I.M. Sechenov First Moscow State Medical University (Sechenov University).
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Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.
Of 1,356 non-industry interventional studies with no phase under Overweight, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 38. This study's planned 24 months is above that.
Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.
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Studies of the drug tested here: Rifaximin
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