HypercholesterolemiaNCT04897113
Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
A study testing plasma exchange with albumin and plasma exchange without albumin in people with Hypercholesterolemia and Hyperbilirubinemia, run by National Medical Research Center for Rehabilitation and Balneology at 2 sites in Russia.
Trial summary
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. Read more about this study
- Who is it for?
- Ages 40 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia, Hyperbilirubinemia, Hyper IgE Syndrome
- What is being tested?
- plasma exchange with albumin and plasma exchange without albumin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesRussia
- Study dates
- 12 May 2021to 30 Dec 2022
- 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 40 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent form.
- Men and women aged 40-55.
- Body mass index <30 kg / m2.
- Level increase of one or several aging markers.
- Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
- Negative pregnancy test for women of childbearing potential.
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- Non-inclusion Criteria:
- Refusal to participate in the study.
- Any health conditions that, according to investigators, might prevent volunteers from participating in the study.
- Mental disorders, past medical history included.
- 10 + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction.
- Drug addiction, chemical abuse.
- Pregnancy or breastfeeding.
- Past medical history of severe allergic reactions.
- General contraindications to plasmapheresis procedures.
- Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals.
Who cannot join
- Voluntary refusal to participate in the study.
- Investigator doctor's decision on participant's exclusion for this participant's own benefit.
- Participant refuses to cooperate with investigator or is undisciplined.
- In case participant misses one or several study procedures or follow-up visits.
- Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
- Positive pregnancy test.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
Moscow, 121099
Ilmira Gilmutdinova, 89686861979, gilm.ilmira@mail.ru
- Recruiting
Orenburg regional clinical blood transfusion station
Orenburg, 460018
Rinat Gilmutdinov, +79033608175, orenrma@mail.ru
About this study
Official title: Multicenter, Open, Prospective, Randomized Trial of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.
Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).
Read the detailed description
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.
One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).
Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality.
- Conditions
- Hypercholesterolemia, Hyperbilirubinemia, Hyper IgE Syndrome, Hyper Beta Lipoproteinemia, Hyper Eosinophilic Syndrome, Hyper-LDL-cholesterolemia
- Being tested
- plasma exchange with albumin, plasma exchange without albumin
- Keywords
- plasmapheresis, plasma exchange, albumin, biomarkers of aging, age-related diseases
- Medical subject headings
- Hypercholesterolemia, Hyperbilirubinemia, Job Syndrome, Hyperlipoproteinemia Type II, Hypereosinophilic Syndrome, Gout, Diabetes Mellitus, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma exchange with albuminProcedure or surgery
Also called plasmapheresis with albumin
plasma exchange with albumin, two per week, 110% of the circulating plasma volume
plasma exchange without albuminProcedure or surgery
Also called plasmapheresis without albumin
plasma exchange without albumin, two per week, 110% of the circulating plasma volume
| Study group | Role | What they receive |
|---|---|---|
| plasmapheresis with albumin compensation | Experimental | a course of hardware plasmapheresis procedures with replacement by colloidal (5% albumin solution) and crystalloid solutions (saline) in a ratio of 1: 3 Receives: Procedure: plasma exchange with albumin |
| plasmapheresis without albumin compensation | Experimental | a course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline). Receives: Procedure: plasma exchange without albumin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count at visit 6, compared with initial values (visit 0).
Measured: 1 month
Secondary outcomes (11)
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Dynamics summary for aging biomarkers' values assessed by a patient's biochemical blood count at visit 5, compared with initial values (visit 0).
Measured: 17 (+/- 2) days
Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count
Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count at visits 5 and 6, compared with initial values (visit 0).
Measured: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test
Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test at visits 5 and 6, compared with initial values (visit 0).
Measured: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test
Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test at visits 5 and 6, compared with initial values (visit 0).
Measured: 1 month
Dynamics of results according to the method of "phenotypic age"
Dynamics of results according to the method of "phenotypic age" assessment with the use of values of complete and biochemical blood counts at visits 5 and 6, compared with initial values (visit 0).
An assessment of the "phenotypic age" will be carried out (Morgan E. et al., 2018). For counting, 10 markers are used: albumin, creatinine, glucose, C-reactive protein, percentage of lymphocytes, average cell volume, distribution width of erythrocytes, alkaline phosphatase, leukocyte count, chronological age.
Measured: 1 month
Dynamics of results according to the method of biological age
Dynamics of results according to the method of biological age assessment with the use of values of complete and biochemical blood counts at visits 5 and 6, compared with initial values (visit 0). The biological age will be assessed by the method of Putin E., Mamoshina P. et al., 2016. The following markers are used for calculation by this method: albumin, glucose, urea, cholesterol, total protein, sodium, creatinine, hemoglobin, total bilirubin, triglycerides , HDL cholesterol, LDL cholesterol (Friedewald), calcium, potassium, hematocrit, MCHC, MCV, platelets, erythrocytes (erythrocytes), weight, height.
An online system available at http://www.aging.ai will be used to estimate biological age.
Measured: 1 month
Dynamic pattern according to ECG results
Dynamic pattern according to ECG results in 12 leads at visits 5 and 6, compared with initial values (visit 0).
Measured: 1 month
Dynamic pattern according to results of vascular ultrasonography
Dynamic pattern according to results of vascular ultrasonography at visits 5 and 6, compared with initial values (visit 0).
Measured: 1 month
SF-36 scale
Change of scores according to every scale out of all 8 scales from the SF-36 questionnaire at visits 5, 6 and 7, compared with initial values (visit 0).
Measured: 1 month
HAM questionnaire
Dynamics of subjective assessment of a patient's current psycho emotional state (HAM questionnaire) at visits 5, 6 and 7, compared with initial values (visit 0). The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
Measured: 1 month
scales of the "Health-Promoting Lifestyle Profile"
Change of scores according to every scale out of 6 scales of the "Health-Promoting Lifestyle Profile" questionnaire at visits 5, 6 and 7, compared with initial values (visit 0).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start12 May 2021 (estimated)
- Primary completion30 Oct 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Medical Research Center for Rehabilitation and Balneology
- Sponsor type
- University, hospital or other
- Collaborators
- The Orenburg Regional Clinical Hospital, DNKOM LLC, Pirogov Russian National Research Medical University
- Responsible party
- Sponsor
- Investigators
- Ilmira Gilmutdinova, Study chair, Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04897113
- Sponsor's protocol ID
- RU-RB-01-01-21 of 08.02.2021
- Status last verified
- May 2021
- First submitted
- 18 May 2021
- Last updated
- 21 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open, Prospective, Randomized Trial of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old
- ClinicalTrials.gov ID
- NCT04897113
- Acronym / sponsor ID
- RU-RB-01-01-21 of 08.02.2021
- Conditions
- Hypercholesterolemia, Hyperbilirubinemia, Hyper IgE Syndrome, Hyper Beta Lipoproteinemia, Hyper Eosinophilic Syndrome, Hyper-LDL-cholesterolemia
- Keywords
- plasmapheresis, plasma exchange, albumin, biomarkers of aging, age-related diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Medical Research Center for Rehabilitation and BalneologyUniversity, hospital or other
- Collaborators
- The Orenburg Regional Clinical Hospital, DNKOM LLC, Pirogov Russian National Research Medical University
- Study start
- 12 May 2021 (estimated)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 21 May 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.
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.
Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).
Detailed description
Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state.
One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).
Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plasmapheresis with albumin compensation | Experimental | Procedure: plasma exchange with albumina course of hardware plasmapheresis procedures with replacement by colloidal (5% albumin solution) and crystalloid solutions (saline) in a ratio of 1: 3 |
| plasmapheresis without albumin compensation | Experimental | Procedure: plasma exchange without albumina course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline). |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Signed informed consent form.
- Men and women aged 40-55.
- Body mass index <30 kg / m2.
- Level increase of one or several aging markers.
- Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
Key exclusion criteria (6 listed)
- Voluntary refusal to participate in the study.
- Investigator doctor's decision on participant's exclusion for this participant's own benefit.
- Participant refuses to cooperate with investigator or is undisciplined.
- In case participant misses one or several study procedures or follow-up visits.
- Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
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 |
|---|---|---|
| plasma exchange with albuminAlso: plasmapheresis with albuminplasma exchange with albumin, two per week, 110% of the circulating plasma volume | Procedure or surgery | plasmapheresis with albumin compensation |
| plasma exchange without albuminAlso: plasmapheresis without albuminplasma exchange without albumin, two per week, 110% of the circulating plasma volume | Procedure or surgery | plasmapheresis without albumin compensation |
Primary outcome
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Time frame: 1 month
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count at visit 6, compared with initial values (visit 0).
11 secondary outcomes
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Time frame: 17 (+/- 2) days
Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count
Time frame: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test
Time frame: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test
Time frame: 1 month
Dynamics of results according to the method of "phenotypic age"
Time frame: 1 month
Dynamics of results according to the method of biological age
Time frame: 1 month
Dynamic pattern according to ECG results
Time frame: 1 month
Dynamic pattern according to results of vascular ultrasonography
Time frame: 1 month
SF-36 scale
Time frame: 1 month
HAM questionnaire
Time frame: 1 month
scales of the "Health-Promoting Lifestyle Profile"
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2021.
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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.
Ilmira Gilmutdinova study chair
Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma exchange with albumin and plasma exchange without albumin in people with Hypercholesterolemia and Hyperbilirubinemia, run by National Medical Research Center for Rehabilitation and Balneology 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 16 inclusion and 6 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 21 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilmira Gilmutdinova (+79686861979, gilm.ilmira@mail.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count (time frame: 1 month). 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 21 May 2021.