The effect of synbiotic use on heart failure

Phase 3

Recruiting

Conditions: Heart failure.
Heart failure

Registration Number: IRCT20091114002709N52

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

Inclusion Criteria

Age range from 30 to 70 years
Patients with systolic heart failure (LVEF <40%) approved by a cardiologist and receiving at least 3 months of standard heart failure treatment , Medications have reached the maximum tolerated dose and their medication dose will remain constant throughout the study.
class 1,2 and 3 of NYHA classification
Willingness to participate in the study and sign informed written consent
Lack of other diseases including chronic and acute liver disorders (hepatitis B, C, etc.), diabetes, thyroid disorders, severe renal dysfunction (300 mmol /l = creatinine ), pulmonary diseases, inflammatory and autoimmune diseases, Cancer, acute infection
Not using any nutritional supplements for the past two months.
No substance abuse and smoking
Not taking Corticosteroids in the past 4 weeks
Failure to receive antibiotics in the past 3 months
No history of gastrointestinal surgery
No anti-inflammatory drugs except low-dose aspirin (one 80 mg daily)
No artificial heart valve
No history of rheumatic heart disease
Not being pregnant and breastfeeding
Lack of insulin
BMI< 30

Exclusion Criteria

Not willing to continue cooperation
use of less than 80% of supplements given to the patient during the study period Acceptance rate = The number of capsules given to the patient - the Number of capsules not used / The number of capsules given to the patient
other disease such as metabolic diseases,Cancer and inflammatory diseases during the study that Need special treatment or antibiotic use.
Changes in the type and dose of drug which is using by the patient .

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
T-probnp. Timepoint: Before and after intervention. Method of measurement: ELISA kit.

Secondary Outcome Measures

Name	Time	Method
Blood pressure. Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: sphygmomanometer.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: Before intervention and 10 weeks after the start of intervention. Method of measurement: immunoturbidimetric tests.