Arterial HypertensionNCT04820556
Gut Microbiota in Chronic Noncommunicable Diseases
An observational study of Arterial Hypertension and Atherosclerosis Occlusive Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 2 sites in Russia.
Trial summary
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Arterial Hypertension, Atherosclerosis Occlusive Disease, Heart Failure With Preserved Ejection Fraction
- How many people
- 1,084 participants
- Where
- 2 sitesRussia
- Study dates
- 12 Apr 2021to 1 Dec 2021
- Phase
- Observational
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic noncommunicable diseases including cardiovascular diseases, type 2 diabetes mellitus, nonalcoholic fatty liver disease, chronic obstructive pulmonary disease, asthma and control group
Who may be able to join
- All mentioned groups:
- Men and women aged ≥ 18 and <80
- Signed informed consent form
- Group of arterial hypertention (inclusion criteria):
- No current treatment of hypertension
- Systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg
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- No clinical signs of other cardiovascular diseases
- Group of COPD and asthma (inclusion criteria)
- Medical records, confirming COPD or asthma
- Regular stable treatment of COPD, asthma or any chronic disease for ≥ 4 weeks before the enrollment. If inhaled corticosteroids are being used, regular treatment is required for ≥12 weeks.
- Absence of acute exacerbations of COPD, asthma or any concomitant diseases 4 weeks before the enrollment
- No use of genetically engineered biological drugs
- For patients with COPD after inhalation of salbutamol (400 mcg) the ratio FEV1/FVC is less than 0,70
- Group of type 2 diabetes mellitus (inclusion criteria)
- Confirmed type 2 diabetes mellitus
- Stable glucose lowering treatment for ≥ 1 month
- No systemic corticosteroid treatment 4 weeks before the enrollment
- Group of NAFLD (inclusion criteria)
- Ultrasound criteria of non-alcoholic fatty liver disease or
- Confirmed non-alcoholic fatty liver disease using FibroMax test
- Control group inclusion criteria
- Men and women aged ≥ 18 and <80 years
- Signed informed consent form
- Control group for arterial hypertension (inclusion criteria):
- 1. No history of cardiovascular diseases, COPD or asthma
- Control group for COPD and asthma (inclusion criteria):
- 1. No history of diabetes mellitus, NAFLD, COPD and asthma
- Men and women aged ≥ 18 and <80 years
- Signs and symptoms of heart failure
- Left ventricular diastolic dysfunction
- Left ventricular ejection fraction ≥50%
- NT-pro BNP >125 pg/ml
- Signed study informed consent form
- Men and women aged ≥ 35 and <80 years
- Signs and symptoms of heart failure
- Left ventricular ejection fraction <50%
- Signed study informed consent form
- Men and women aged ≥ 35 and <80 years
- Symptoms and signs of obstructive atherosclerosis of any vascular bed:
- Ischemic heart disease or
- Revascularization of coronary, renal, brachiocephalic or lower extremity arteries or
- carotid endarterectomy or
- chronic lower extremity ischemia or
- history of myocardial infarction, stroke, transient ischemic attack or
- renovascular AH
- atherosclerotic aorta aneurysm
- Signed study informed consent form
- Inclusion criteria for control group for HF-pEF, HF-rEF and obstructive atherosclerosis
- Men and women aged ≥ 18 and <80 years.
- No signs or symptoms of chronic heart failure
- No signs of left ventricular diastolic dysfunction
- No history, signs or symptoms of obstructive atherosclerosis of any vascular bed
- Signed study informed consent form
- Exclusion criteria for groups with HF-pEF, HF-rEF and obstructive atherosclerosis:
- Age <18 and ≥80 years.
- Refuse to sign study informed consent form
- Body mass index ≥35 kg/m2
- Chronic kidney disease with GFR <30 ml/min/1,73 m2
- Current smoking
- Moderate or severe COPD
- Moderate or severe asthma
- Acute infections or exacerbation of chronic infections 2 weeks prior to study enrollment
- History of allergic reactions to gadolinium contrast
- Hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy: primary, amyloidosis, glycogen storage diseases, hemochromatosis, sarcoidosis, drug induced cardiomyopathy, radiation heart disease, constrictive pericarditis).
- Connective tissue disease
- Cancer with no radical treatment
- Pregnancy or lactation
- Inflammatory bowel disease
- Use of antimicrobial agents, probiotics or systemic corticosteroids 3 months before the enrollment
Who cannot join
- Age < 18 years and ≥80 years
- Denial of further participation
- Obesity with BMI≥40 kg/m2
- History of organ transplantion
- Psychiatric disorder, limiting participation in the study
- Acute infections
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- Exacerbation of chronic infection 2 weeks before the enrollment
- Cancer with no radical treatment
- Pregnancy and lactation
- Alcohol and drug addition
- Chronic kidney disease with GFR <30 ml/min/1.73m2
- Systemic autoimmune diseases
- Inflammatory bowel disease
- Antimicrobial and probiotic treatment 3 months before the enrollment
- Additional exclusion criteria adjusted for each group
- Group of arterial hypertension (exclusion criteria):
- Ischemic heart disease (angina pectoris, myocardial infarction), cerebrovascular disease (stroke, transient ischemic attack), occlusive peripheral arterial disease, revascularization of any vascular bed.
- Cardiomyopathies
- Symptomatic arterial hypertension
- Diabetes mellitus
- Signs of previous myocardial infarction on ECG
- Arrhythmias (parohysmal arrhythmias, atrial fibrillation, sinoatrial block, atrioventricular block grade II-III)
- Signs of current myocardial ischemia on ECG
- Decompensated heart failure
- Group of COPD and asthma (exclusion criteria):
- Exacerbation of COPD or asthma 3 months before the enrollment which required antibiotic treatment or systemic corticosteroids.
- Group of type 2 diabetes mellitus (exclusion criteria):
- Type 1 diabetes mellitus and other specific types of diabetes
- Severe microangiopathy: proliferative and terminal stage of diabetic retinopathy, chronic kidney disease (GFR < 30 ml/min/1,73 m2) for patients with type 2 diabetes
- The history of moderate, severe and very severe COPD
- The history of moderate or severe asthma
- Vegetarians or vegans
- Group of non-alcoholic fatty liver disease (exclusion criteria):
- Chronic liver diseases except NAFLD
- The history of moderate, severe and very severe COPD
- The history of moderate or severe asthma
- Vegetarians or vegans
- Diabetes mellitus
- Criteria for groups of heart failure and obstructive atherosclerosis (retrospective)
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
National Medical Research Center for Therapy and Preventive Medicine of the Ministry of Healthcare of the Russian Federation
Moscow, 101990
Centre for Strategic Planning and Management of Biomedical Health Risks of the Federal Medical Biological Agency
Moscow, 119121
About this study
Official title: The Development of Preventive Methods for Chronic Noncommunicable Diseases Based on Modulation of Gut Microbiota Composition and Function
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. The study has a prospective part planned for 2021 and a retrospective part which includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut microbiota composition, its metabolites, levels of inflammatory and other markers of the disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control patients) as well as in retrospective groups (chronic heart failure with preserved and reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate the association between gut microbiota composition and its metabolites, levels of inflammatory and other markers of the disease in retrospective and prospective groups.
- Conditions
- Arterial Hypertension, Atherosclerosis Occlusive Disease, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Type 2, Obstructive Pulmonary Disease
- Keywords
- chronic noncommunicable diseases, gut permeability, inflammation, gut microbiota
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2, Lung Diseases, Obstructive, Asthma, Non-alcoholic Fatty Liver Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Arterial hypertension | Not described | |
| Atherosclerosis occlusive disease | Not described | |
| Heart failure with preserved ejection fraction | Not described | |
| Heart failure with reduced ejection fraction | Not described | |
| Diabetes mellitus, type 2 | Not described | |
| Chronic obstructive pulmonary disease and asthma | Not described | |
| Nonalcoholic fatty liver disease | Not described | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide
Measured: on enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start12 Apr 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial HypertensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 1,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Therapy and Preventive Medicine
- Sponsor type
- Other government
- Collaborators
- Center for Strategic Planning and Management of Biomedical Health Risks of the Federal Biomedical Agency
- Responsible party
- Principal investigator, Anastasia Kaburova, National Medical Research Center for Therapy and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820556
- Sponsor's protocol ID
- 3162021
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2021
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Preventive Methods for Chronic Noncommunicable Diseases Based on Modulation of Gut Microbiota Composition and Function
- ClinicalTrials.gov ID
- NCT04820556
- Acronym / sponsor ID
- 3162021
- Conditions
- Arterial Hypertension, Atherosclerosis Occlusive Disease, Heart Failure With Preserved Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Diabetes Mellitus, Type 2, Obstructive Pulmonary Disease
- Keywords
- chronic noncommunicable diseases, gut permeability, inflammation, gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,084 participants (actual)
- Lead sponsor
- National Medical Research Center for Therapy and Preventive MedicineOther government
- Collaborators
- Center for Strategic Planning and Management of Biomedical Health Risks of the Federal Biomedical Agency
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 29 Mar 2021 (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.
It is an observational study in patients with chronic noncommunicable diseases (i.e. cardiovascular diseases, diabetes mellitus, non-alcoholic fatty liver disease, chronic obstructive pulmonary disease and asthma ) and control group with no signs of these conditions. The study has a prospective part planned for 2021 and a retrospective part which includes the patients enrolled between 2018-2020. The aim of the study is to investigate gut microbiota composition, its metabolites, levels of inflammatory and other markers of the disease in prospective groups (arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease and control patients) as well as in retrospective groups (chronic heart failure with preserved and reduced ejection fraction, obstructive atherosclerosis of any vascular bed, arterial hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma, non-alcoholic fatty liver disease, and control patients). Also we are planning to investigate the association between gut microbiota composition and its metabolites, levels of inflammatory and other markers of the disease in retrospective and prospective groups.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Arterial hypertension | – | – |
| Atherosclerosis occlusive disease | – | – |
| Heart failure with preserved ejection fraction | – | – |
| Heart failure with reduced ejection fraction | – | – |
| Diabetes mellitus, type 2 | – | – |
| Chronic obstructive pulmonary disease and asthma | – | – |
| Nonalcoholic fatty liver disease | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic noncommunicable diseases including cardiovascular diseases, type 2 diabetes mellitus, nonalcoholic fatty liver disease, chronic obstructive pulmonary disease, asthma and control group
Key inclusion criteria (69 listed)
- Men and women aged ≥ 18 and <80
- Signed informed consent form
- No current treatment of hypertension
- Systolic blood pressure <180 mm Hg and diastolic blood pressure <110 mm Hg
- No clinical signs of other cardiovascular diseases
Key exclusion criteria (39 listed)
- Age < 18 years and ≥80 years
- Denial of further participation
- Obesity with BMI≥40 kg/m2
- History of organ transplantion
- Psychiatric disorder, limiting participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide
Time frame: on enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Hypertension and Atherosclerosis Occlusive Disease, run by National Medical Research Center for Therapy and Preventive Medicine at 2 sites in Russia.
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 69 inclusion and 39 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: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant (p<0,05) correlation (r>0,5) between abundance of Faecalibacterium genus and concentration of lipopolysaccharide (time frame: on enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2022.