About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years
Residing in the city of Astana and surrounding regions (Akmola region)
Diagnosis of heart failure according to internationally recognized guidelines and classified as Class I-IV by NYHA (New York Heart Association) or Stage A-C according to ACC/AHA (American College of Cardiology/American Heart Association) classification
Clinically stable condition and optimized medication therapy for heart failure for at least 4 weeks in accordance with current recommendations
Disqualifiers
• Age under 18 years
Refusal to undergo diagnostic procedures specified in the study protocol
Terminal stage of heart failure (Stage D according to ACC/AHA classification)
Coronary or peripheral revascularization procedures, valvular procedures, or any major surgical procedure within 3 months prior to study enrollment
Trial design
Parallel
Treatments tested in this trial
Probiotic
Dietary supplementPatients will receive the product twice a day, a single dose of the product is packaged in sachets. The product can be hired in the form of a powder or diluted with a small amount of water. The general course is 90 days.
Placebo
Dietary supplementPatients will receive the product twice a day, a single dose of the product is packaged in sachets. The product can be hired in the form of a powder or diluted with a small amount of water. The general course is 90 days.
Treatment groups
Trial outcomes
Primary outcomes
Gut microbiome
Changes in gut microbiota composition \[Timepoints: baseline, after 3 months of probiotic intake\]
Secondary outcomes
Frequency of hospitalizations
Frequency of hospitalizations and cardiovascular mortality \[Timepoints: baseline, after 3 months of probiotic intake\]
Sponsors and contacts
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