Investigating the gut microbiome's role in chronic heart failure

Development of a Panel of Microbiome Markers for Predicting CHF Outcomes

This study is testing whether taking probiotics can change the gut bacteria in people with chronic heart failure and see if that helps their heart health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nazarbayev University (other)
• Locations: 1 site (Astana)
• Trial ID: NCT06573892 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to establish a causal relationship between gut microbiome composition and chronic heart failure (HF) by utilizing probiotics to modify gut microbiota. Patients will be divided into three groups based on their echocardiographic findings: HF with preserved ejection fraction, mildly reduced ejection fraction, and reduced ejection fraction. A double-blind, randomized, placebo-controlled design will be employed, with participants undergoing thorough medical evaluations and assessments of heart failure symptoms. The study will also explore the interaction of probiotics with other heart failure medications to understand their potential anti-inflammatory effects.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with a diagnosis of chronic heart failure classified as Class I-IV by NYHA and residing in Astana or surrounding regions.

Not a fit: Patients in the terminal stage of heart failure or those who have undergone major surgical procedures recently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new probiotic treatments that improve heart failure management and patient outcomes.

How similar studies have performed: While many studies have explored the gut microbiome's association with various conditions, this approach using probiotics in heart failure is relatively novel and untested.

Eligibility criteria

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 this trial is running

Astana

• Heart Center — Astana, Kazakhstan (RECRUITING)

Study contacts

• Study coordinator: Almagul Kushugulova

Conditions: Heart Failure