The Gut Microbiome in Chronic Heart Failure
Recruiting · NCT06573892 · Interventional (participants receive a specific treatment) · Lead sponsor: Nazarbayev University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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
- Willingness to participate in the study
Exclusion criteria
- • 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
- Use of antibiotics, cytostatic therapy, or pro- or prebiotics within 1 month prior to the baseline visit
- Presence of oncological and autoimmune diseases (connective tissue diseases, gastrointestinal disorders, skin disorders, etc.)
- Acute illness or active infection
- Individual intolerance to the administered nutrients (probiotics)
- Presence of other anatomical or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study, comply with the requirements of subsequent follow-up, or affect the scientific validity of the clinical study results.
Where it is running
1 location listed.
- Heart Center - Astana, Kazakhstan