Heart FailureGMCHFNCT06573892
The Gut Microbiome in Chronic Heart Failure
A study testing Probiotic in people with Heart Failure, run by Nazarbayev University at 1 site in Kazakhstan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Oct 2024to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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.)
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- 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.
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site, 1 recruiting
- Recruiting
Heart Center
Astana, 010000
Almagul Kushugulova, +77172706498, akushugulova@nu.edu.kz
About this study
Official title: Development of a Panel of Microbiome Markers for Predicting CHF Outcomes
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.
Read the 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 reduced EF (EF 49-40%) HF with reduced EF (EF < 40%) From each subgroup, 60 patients will be randomly selected to participate in a double-blind, randomized, placebo-controlled trial of probiotic therapy.
The control group will consist of individuals selected from outpatient clinics in the city of Astana, matched by gender and age, who are healthy in terms of cardiovascular and other systemic pathologies, not in an acute phase of any illness, willing to participate in the study, and have signed informed consent.
For each patient, a medical history will be collected, a physical examination will be performed to assess their clinical condition, the severity of heart failure symptoms will be evaluated using a severity scale (ANA/ACC), functional classes will be determined according to NYHA (6-minute walk test), echocardiographic examination will be conducted, and if indicated, electrocardiogram (ECG) monitoring using a Holter monitor will be performed. The physical examination will include lung auscultation, cardiac auscultation, assessment of peripheral edema, assessment of jugular venous pulse height, body weight, height, and height at the age of 20. Further investigations will be guided by symptoms. Echocardiographic examination will be performed using a diagnostic ultrasound device, Philips Ultrasound Inc., CX50. The 12-lead ECG will be recorded in the supine position. ECG intervals (PR, QRS, QT, QTc), heart rate, and any abnormalities (rhythm anomalies, AV block, pathological Q waves, bundle branch block, repolarization disturbances) will be recorded for each subject.
Clinical and laboratory parameters:
The following analyses will be performed:
- Complete blood count with differential leukocyte count
- Total/direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH)
- Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides
- Serum glucose, glycosylated hemoglobin (HbA1c)
- Blood electrolytes (sodium, potassium, chloride), creatinine, blood urea nitrogen (BUN), uric acid
- Glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, gamma-glutamyl transferase (GGT)
- Creatine phosphokinase, troponin I
- Thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4)
- Conditions
- Heart Failure
- Being tested
- Probiotic, Placebo
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Also called mare's milk
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.
PlaceboDietary supplement
Also called caw milk
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Probiotic; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut microbiome
Changes in gut microbiota composition [Timepoints: baseline, after 3 months of probiotic intake]
Measured: 90 days
Secondary outcomes (1)
Frequency of hospitalizations
Frequency of hospitalizations and cardiovascular mortality [Timepoints: baseline, after 3 months of probiotic intake]
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion25 Dec 2024 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model 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 reduced EF (EF 49-40%) HF with reduced EF (EF \< 40%)
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nazarbayev University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Almagul Kushugulova, Nazarbayev University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573892
- Sponsor's protocol ID
- BR21882152
- Acronym
- GMCHF
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40470050
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Panel of Microbiome Markers for Predicting CHF Outcomes
- ClinicalTrials.gov ID
- NCT06573892
- Acronym / sponsor ID
- GMCHF / BR21882152
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nazarbayev UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 27 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 reduced EF (EF 49-40%) HF with reduced EF (EF < 40%) From each subgroup, 60 patients will be randomly selected to participate in a double-blind, randomized, placebo-controlled trial of probiotic therapy.
The control group will consist of individuals selected from outpatient clinics in the city of Astana, matched by gender and age, who are healthy in terms of cardiovascular and other systemic pathologies, not in an acute phase of any illness, willing to participate in the study, and have signed informed consent.
For each patient, a medical history will be collected, a physical examination will be performed to assess their clinical condition, the severity of heart failure symptoms will be evaluated using a severity scale (ANA/ACC), functional classes will be determined according to NYHA (6-minute walk test), echocardiographic examination will be conducted, and if indicated, electrocardiogram (ECG) monitoring using a Holter monitor will be performed. The physical examination will include lung auscultation, cardiac auscultation, assessment of peripheral edema, assessment of jugular venous pulse height, body weight, height, and height at the age of 20. Further investigations will be guided by symptoms. Echocardiographic examination will be performed using a diagnostic ultrasound device, Philips Ultrasound Inc., CX50. The 12-lead ECG will be recorded in the supine position. ECG intervals (PR, QRS, QT, QTc), heart rate, and any abnormalities (rhythm anomalies, AV block, pathological Q waves, bundle branch block, repolarization disturbances) will be recorded for each subject.
Clinical and laboratory parameters:
The following analyses will be performed:
- Complete blood count with differential leukocyte count
- Total/direct bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH)
- Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), triglycerides
- Serum glucose, glycosylated hemoglobin (HbA1c)
- Blood electrolytes (sodium, potassium, chloride), creatinine, blood urea nitrogen (BUN), uric acid
- Glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, gamma-glutamyl transferase (GGT)
- Creatine phosphokinase, troponin I
- Thyroid-stimulating hormone (TSH), triiodothyronine (T3), thyroxine (T4)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model 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 reduced EF (EF 49-40%) HF with reduced EF (EF < 40%)
| Arm | Type | Receives |
|---|---|---|
| Probiotic. Heart Failure | Active comparator | Dietary Supplement: Probiotic, Dietary Supplement: PlaceboThe 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 |
| Placebo. Heart Failure | Placebo comparator | Dietary Supplement: Probiotic, Dietary Supplement: PlaceboThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- • Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticAlso: mare's milkPatients 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. | Dietary supplement | Placebo. Heart Failure, Probiotic. Heart Failure |
| PlaceboAlso: caw milkPatients 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. | Dietary supplement | Placebo. Heart Failure, Probiotic. Heart Failure |
Primary outcome
Gut microbiome
Time frame: 90 days
Changes in gut microbiota composition [Timepoints: baseline, after 3 months of probiotic intake]
1 secondary outcome
Frequency of hospitalizations
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Derived from this study: PubMed 40470050Issilbayeva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Heart Failure, run by Nazarbayev University at 1 site in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Almagul Kushugulova (+77171706498, akushugulova@nu.edu.kz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiome (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06573892, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.