The Gut Microbiome in Chronic Heart Failure

NCT06573892 | Recruiting DMC

• 1 other identifier: BR21882152
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Gut microbiome

  Changes in gut microbiota composition \[Timepoints: baseline, after 3 months of probiotic intake\]

  90 days

Secondary Outcomes (1)

• Frequency of hospitalizations

  2 years

Study Arms (2)

Probiotic. Heart Failure

ACTIVE COMPARATOR

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 reduced EF (EF 49-40%) HF with reduced EF (EF \< 40%) 30 patients in each group

Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Placebo. Heart Failure

PLACEBO COMPARATOR

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 reduced EF (EF 49-40%) HF with reduced EF (EF \< 40%) 30 patients in each group

Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Patients 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.

Also known as: mare's milk

Placebo. Heart Failure; Probiotic. Heart Failure

Placebo DIETARY_SUPPLEMENT

Patients 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.

Also known as: caw milk

Placebo. Heart Failure; Probiotic. Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nazarbayev University: lead

Study Sites (1)

Heart Center

Astana, 010000, Kazakhstan

RECRUITING

Related Publications (1)

• Issilbayeva A, Sergazy S, Zhashkeyev A, Gulyayev A, Kozhakhmetov S, Shulgau Z, Nurgaziyev M, Nurgaziyeva A, Zhetkenev S, Mukhanbetzhanov N, Jarmukhanov Z, Mukhanbetzhanova Z, Vinogradova E, Zhumadilov Z, Kushugulova A, Aljofan M. Polyphenol-mediated microbiome modulation in STEMI patients: a pilot study. Front Med (Lausanne). 2025 May 21;12:1522373. doi: 10.3389/fmed.2025.1522373. eCollection 2025.

  PMID: 40470050 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Almagul Kushugulova

CONTACT

+77171706498; akushugulova@nu.edu.kz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist

Model Details: 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 reduced EF (EF 49-40%) HF with reduced EF (EF \< 40%)

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 27, 2024
• Study Start: October 1, 2024
• Primary Completion: December 25, 2024
• Study Completion: October 31, 2025
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KA (1)