Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction

NCT06652087 | Recruiting

• 1 other identifier: VI27478
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Bacterial Overgrowth Syndrome Small Bowel; Heart Failure with Preserved Ejection Fraction

Keywords

Chronic heart failure with preserved ejection fraction; Diastolic dysfunction; Overweight; Obesity; The gut-heart axis; Small intestinal bacterial overgrowth syndrome

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Day 1, day 40

Secondary Outcomes (7)

• Changes in the level of C-reactive protein in blood serum

  Day 1, day 40

• Changes in serum fibrinogen levels

  Day 1, day 40

• Changes in serum ferritin levels

  Day 1, day 40

• Change in the presence of the small intestinal bacterial overgrowth

  Day 2, day 10, day 40

• Change in the maximum volume of the left atrium indexed to the body surface area

  Day 1, day 40

Study Arms (2)

intervention group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

Patients of the control group will receive standart therapy HFpEF Without Rifaximin

Other: Standard HFpEF treatment

Interventions

Rifaximin DRUG

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®

intervention group

Standard HFpEF treatment OTHER

diuretic, including an aldosterone antagonist; sodium-glucose cotransporter-2 inhibitor

control group; intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• refusal of the patient from further participation in the study

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Moscow

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Rifaximin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Vladimir Ivashkin

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Konstantin Ivashkin

CONTACT

+7 926 213 58 33; ivashkin_k_v@staff.sechenov.ru

Elena Bueverova

CONTACT

+7 916 526 6245; bueverova_e_l@staff.sechenov.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The participants are divided into two parallel groups for the duration of the study. Forty patients with HFRS with a body mass index of more than 25 kg/m2 and a positive SIBO test will be randomly assigned in a 1:1 ratio to the experimental (rifaximin) and control groups. All patients will also receive standard HF treatment (diuretics, including an aldosterone antagonist; a sodium-glucose cotransporter-2 inhibitor).

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: October 22, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)