RecruitingNot ApplicableNCT06652087

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

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

Sponsor

I.M. Sechenov First Moscow State Medical University

Enrollment

40 participants

Start Date

Sep 2, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction Bacterial Overgrowth Syndrome Small Bowel

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether rifaximin — an antibiotic that acts mainly in the gut — can improve heart function in patients with a type of heart failure where the heart pumps normally but the heart muscle is stiff (called heart failure with preserved ejection fraction, or HFpEF). The idea is that gut bacteria may play a role in this condition. **You may be eligible if...** - You are between 18 and 80 years old - You have a body mass index (BMI) of 25 or higher (overweight or obese) - You have been diagnosed with HFpEF (heart failure with preserved ejection fraction, meaning the heart pumps at least 50% of blood with each beat) - You have elevated levels of a heart stress marker called NT-proBNP **You may NOT be eligible if...** - You have heart failure where the heart pumps weakly (ejection fraction below 50%) - You have a serious infection or another major illness - You are unwilling or unable to continue in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRifaximin

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

OTHERStandard HFpEF treatment

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