Status:
RECRUITING
The Gut Microbiome in Chronic Heart Failure
Lead Sponsor:
Nazarbayev University
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 rela...
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...
Eligibility Criteria
Inclusion
- 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
- • 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06573892
Start Date
October 1 2024
End Date
October 31 2025
Last Update
August 27 2024
Active Locations (1)
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1
Heart Center
Astana, Kazakhstan, 010000