Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573892
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
The Gut Microbiome in Chronic Heart Failure
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Panel of Microbiome Markers for Predicting CHF Outcomes
Status:
RECRUITING
Status Verified Date:
2024-08
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:
GMCHF
Brief Summary:
there are numerous studies most of which are predominantly associative in nature investigating the association between the gut microbiota and various pathologies However to establish a causal relationship between microbiome composition and chronic heart failure HF clinical studies are needed particularly using probiotics that can modify the composition and function of the gut microbiota Examining their effects on HF can help understand which specific changes are associated with improvement or slowing the progression of the disease The gut microbiome plays an important role in regulating the immune system and inflammatory processes Investigating the impact of probiotics on these mechanisms may reveal their potential anti-inflammatory and immunomodulatory properties which can be beneficial for controlling the inflammation characteristic of HF Additionally studying the interaction of probiotics with other medications such as antihypertensive and diuretic agents can be crucial for optimizing pharmacotherapy in HF patients Confirming the role of the gut microbiota in the pathogenesis of HF and further developing probiotic therapy may lead to improved prognosis and treatment outcomes for HF patients Overall conducting a clinical study using probiotics in HF has the potential to expand our knowledge of the role of the gut microbiota in this disease and lay the groundwork for the development of new treatment strategies
Detailed Description:
The patient sample will be divided into three main groups based on clinical phenotypes determined by echocardiographic examination
HF with preserved ejection fraction EF EF 50 HF with mildly reduced EF EF 49-40 HF with reduced EF EF 40 From each subgroup 60 patients will be randomly selected to participate in a double-blind randomized placebo-controlled trial of probiotic therapy
The control group will consist of individuals selected from outpatient clinics in the city of Astana matched by gender and age who are healthy in terms of cardiovascular and other systemic pathologies not in an acute phase of any illness willing to participate in the study and have signed informed consent
For each patient a medical history will be collected a physical examination will be performed to assess their clinical condition the severity of heart failure symptoms will be evaluated using a severity scale ANAACC functional classes will be determined according to NYHA 6-minute walk test echocardiographic examination will be conducted and if indicated electrocardiogram ECG monitoring using a Holter monitor will be performed The physical examination will include lung auscultation cardiac auscultation assessment of peripheral edema assessment of jugular venous pulse height body weight height and height at the age of 20 Further investigations will be guided by symptoms Echocardiographic examination will be performed using a diagnostic ultrasound device Philips Ultrasound Inc CX50 The 12-lead ECG will be recorded in the supine position ECG intervals PR QRS QT QTc heart rate and any abnormalities rhythm anomalies AV block pathological Q waves bundle branch block repolarization disturbances will be recorded for each subject
Clinical and laboratory parameters
The following analyses will be performed
Complete blood count with differential leukocyte count
Totaldirect bilirubin aspartate aminotransferase AST alanine aminotransferase ALT lactate dehydrogenase LDH
Total cholesterol high-density lipoprotein HDL low-density lipoprotein LDL triglycerides
Serum glucose glycosylated hemoglobin HbA1c
Blood electrolytes sodium potassium chloride creatinine blood urea nitrogen BUN uric acid
Glutamic-oxaloacetic transaminase glutamic-pyruvic transaminase gamma-glutamyl transferase GGT
Creatine phosphokinase troponin I
Thyroid-stimulating hormone TSH triiodothyronine T3 thyroxine T4
HF with preserved ejection fraction EF EF 50 HF with mildly reduced EF EF 49-40 HF with reduced EF EF 40 From each subgroup 60 patients will be randomly selected to participate in a double-blind randomized placebo-controlled trial of probiotic therapy
The control group will consist of individuals selected from outpatient clinics in the city of Astana matched by gender and age who are healthy in terms of cardiovascular and other systemic pathologies not in an acute phase of any illness willing to participate in the study and have signed informed consent
For each patient a medical history will be collected a physical examination will be performed to assess their clinical condition the severity of heart failure symptoms will be evaluated using a severity scale ANAACC functional classes will be determined according to NYHA 6-minute walk test echocardiographic examination will be conducted and if indicated electrocardiogram ECG monitoring using a Holter monitor will be performed The physical examination will include lung auscultation cardiac auscultation assessment of peripheral edema assessment of jugular venous pulse height body weight height and height at the age of 20 Further investigations will be guided by symptoms Echocardiographic examination will be performed using a diagnostic ultrasound device Philips Ultrasound Inc CX50 The 12-lead ECG will be recorded in the supine position ECG intervals PR QRS QT QTc heart rate and any abnormalities rhythm anomalies AV block pathological Q waves bundle branch block repolarization disturbances will be recorded for each subject
Clinical and laboratory parameters
The following analyses will be performed
Complete blood count with differential leukocyte count
Totaldirect bilirubin aspartate aminotransferase AST alanine aminotransferase ALT lactate dehydrogenase LDH
Total cholesterol high-density lipoprotein HDL low-density lipoprotein LDL triglycerides
Serum glucose glycosylated hemoglobin HbA1c
Blood electrolytes sodium potassium chloride creatinine blood urea nitrogen BUN uric acid
Glutamic-oxaloacetic transaminase glutamic-pyruvic transaminase gamma-glutamyl transferase GGT
Creatine phosphokinase troponin I
Thyroid-stimulating hormone TSH triiodothyronine T3 thyroxine T4
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