An interventional study of Probiotic and Placebo in Heart Failure, sponsored by Nazarbayev University. Recruiting at 1 site in Kazakhstan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Nazarbayev University · Not applicable, Interventional, and Basic science
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.
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:
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 90 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Nazarbayev University is the lead sponsor of 15 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Age under 18 years
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Gut microbiome
Changes in gut microbiota composition \[Timepoints: baseline, after 3 months of probiotic intake\]
Time frame: 90 days
Frequency of hospitalizations
Frequency of hospitalizations and cardiovascular mortality \[Timepoints: baseline, after 3 months of probiotic intake\]
Time frame: 2 years
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Dec 2024, 2 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 2 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Probiotic
Nazarbayev University