Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652087
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
Rifaximin and Cardiac Function in Patients with Heart Failure with Preserved Ejection Fraction
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIBO-HFpEF
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
Detailed Description:
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 kgm2 and a positive SIBO test will be randomly assigned in a ratio of 11 to the experimental rifaximin and control groups To detect SIBO a hydrogen breathing test with lactulose Duphalac Abbott Biologicals BV the Netherlands registration number N01171702 dated 02042010 will be performed on a medical device Respiratory hydrogen Gastro GastrolyzerEC60 with accessories Bedfont Scientific Ltd Great Britain registration number 201006253 dated 09172020 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 SPA Italy registration number LS-001993 08312010 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 outPatients 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 BMI25 kgm2 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 BMI25 kgm2 improves their quality of life and prognosis
Forty patients with HFpEF with a body mass index of more than 25 kgm2 and a positive SIBO test will be randomly assigned in a ratio of 11 to the experimental rifaximin and control groups To detect SIBO a hydrogen breathing test with lactulose Duphalac Abbott Biologicals BV the Netherlands registration number N01171702 dated 02042010 will be performed on a medical device Respiratory hydrogen Gastro GastrolyzerEC60 with accessories Bedfont Scientific Ltd Great Britain registration number 201006253 dated 09172020 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 SPA Italy registration number LS-001993 08312010 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 outPatients 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 BMI25 kgm2 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 BMI25 kgm2 improves their quality of life and prognosis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None