COVID-19NCT05379608
Intermittent Hypoxic-hyperoxic Training in Patients With Cardiovascular Pathology After COVID-19 Infection.
A study testing Intermittent hypoxic-hyperoxic training in people with COVID-19 and Chronic Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site in Russia.
Trial summary
Aim of this prospective, interventional, single-center, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training (IHHT) as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- COVID-19, Chronic Heart Failure, Hypertension
- What is being tested?
- Intermittent hypoxic-hyperoxic training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteRussia
- Study dates
- 10 Dec 2021to 30 Apr 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent to participate in the study;
- Age 40 and over;
- Male and female;
- One or more cardiovascular pathologies in the anamnesis:
- a reliably confirmed diagnosis of hypertension, stage I-III (the diagnosis was made in accordance with the National Clinical Guidelines - 2019);
- stable angina pectoris I-III functional class, confirmed by complaints, anamnesis and physical examination and with the help of diagnostic tests (bicycle ergometry or daily electrocardiography monitoring);
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- confirmed diagnosis of arrhythmias and conduction disorders based on electrocardiography data and 24-hour Holter monitoring (premature depolarization, supraventricular tachycardia, atrial fibrillation, sick sinus syndrome, atrioventricular block I-II, bundle branch blocks);
- chronic heart failure stage I-IIB, I-III functional class (New York Heart Association Functional Classification), confirmed by the presence of clinical signs and at least one of two criteria: myocardial dysfunction of left ventricle or / and an increase in the level of the N-terminal fragment of brain natriuretic peptide over 125 pg / ml;
- the presence of signs of systolic or diastolic dysfunction of the left ventricle according to echocardiography.
- COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing, enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree of 3 or higher.
- Non-inclusion criteria:
- Acute infectious diseases, tuberculosis;
- Chronic somatic diseases in the acute stage;
- Congenital anomalies of the heart and large vessels;
- Valvular heart defects (congenital and acquired);
- Severe atherosclerosis of the lower extremities'vessels (chronic ischemia of the lower extremities,stage 3-4);
- Acute decompensated heart failure (II-IV class according to Killip classification);
- Chronic heart failure IV functional class (New York Heart Association Functional Classification classification);
- Secondary arterial hypertension;
- Acute coronary syndrome within 4 weeks before the start of the study;
- Life-threatening rhythm and conduction disturbances;
- Bronchial asthma with the development of respiratory failure II-III degree;
- Acute cerebrovascular accident within the last 4 months;
- Chronic kidney disease (glomerular filtration rate<30 ml / min / 1.73 m2 via CKD-EPI (chronic kidney disease epidemiology collaboration) formula);
- Pregnancy;
- Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
- Oncology, diagnosed within a year or receiving a course of radiation / chemotherapy for cancer at the present time;
- Severe cognitive impairment (MOS) and clinically significant anxiety and / or depression (HADS) interfering with observation;
- Individual intolerance to oxygen deficiency.
Who cannot join
- Refusal to further participation in the study;
- Acute psychotic reactions arising in the process of the study;
- Exacerbation of chronic diseases, requiring a change in patient management tactics and preventing his or her further participation in the study.
Trial locations and contacts
1 site in 1 country.
Russia1 site
University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University (Institute for personalized cardiology, Center "Digital biodesign and personalized healthcare").
Moscow, 119435
About this study
Official title: Intermittent Hypoxic-hyperoxic Training for the Rehabilitation in Patients With Cardiovascular Pathology After COVID-19 Infection.
Aim of this prospective, interventional, single-center, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training (IHHT) as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection.
The study will include 60 patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University. The patients will be divided into 2 groups (intervention and control groups).
Read more
Intervention group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2 5 times a week for 3 weeks, while control group will undergo a simulated IHHT.
All the patients will undergo identical laboratory and instrumental testing before IHHT, after the last IHHT procedure, in a month after the last IHHT procedure and in 6 months.
Estimated result of the study is to confirm or refute the hypothesis of the study that a three-week course of IHHT in patients with cardiovascular pathology in the early period after coronavirus infection can improve exercise tolerance, as well as the quality of life and psychoemotional status, and affect the dynamics of laboratory and instrumental parameters.
Read the detailed description
Aim of this prospective, interventional, single-centered, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection.
The study will include 60 patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
Patients will be randomized via the random number table method into two groups, comparable by gender, age and comorbidity:
Intermittent hypoxic-hyperoxic training (intervention group) group, 30 patients who will receive 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks. Patients in the IHHT group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2.
A control group of 30 patients will undergo a simulated IHHT course with the same "exposure" time and number of sessions. Patients of this group will breathe normoxic gas mixture using the same equipment; ordinary humidified air is supplied through the mask during the entire session.
Patients eligible for inclusion will undergo the following investigations:
- Anamnesis and complaints collection; physical examination;
- Assessment of the quality of life and psycho-emotional status using the Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS) questionnaires, as well as the six-minute walk test;
- General and biochemical blood tests , urine analysis, , determination of markers of inflammation (ferritin, C-reactive protein, D-dimer, fibrinogen, interleukin-1, interleukin-6, interleukin-18 and tumor necrosis factor), the level of Endothelin-1 and nitric oxide (NO) in the blood;
- Electrocardiography, a flow mediated dilatation procedure for endothelial function assessment,transthoracic echocardiography to identify the structural and functional features of the myocardium, spiroergometry to determine the patient's oxygen consumption.
The statistical processing will be performed using the Python Software Foundation version 3.8 for Windows (Delaware, USA).
Estimated result of the study is to confirm or refute the hypothesis of the study that a three-week course of IHHT in patients with cardiovascular pathology in the early stages after suffering a coronavirus infection can improve exercise tolerance, as well as the quality of life and psychoemotional status, and affect the dynamics of laboratory and instrumental parameters.
- Conditions
- COVID-19, Chronic Heart Failure, Hypertension, Arrhythmia, Conduct Disorder, Chronic Coronary Syndrome
- Being tested
- Intermittent hypoxic-hyperoxic training, Intermittent hypoxic-hyperoxic training/control
- Keywords
- COVID-19, inflammation, intermittent hypoxic-hyperoxic training, markers of inflammation, flow mediated dilatation
- Medical subject headings
- COVID-19, Hypertension, Arrhythmias, Cardiac, Conduct Disorder, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxic-hyperoxic trainingProcedure or surgery
IHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019).
Each patient will undergo a hypoxic test to assess the individual response to hypoxia. The minimum safe SpO2 value is 82%, and the maximum allowable heart rate increase during exercise is + 50% of the starting value. When these parameters are reached, an automatic switch to the supply of a hyperoxic gas mixture (35-40% oxygen) occurs till the SpO2 level is 100%. During each training session a hypoxic gas mixture is supplied to the patient in an intermittent mode, alternating with the supply of a hyperoxic gas mixture. On average, each workout includes 6 of the above cycles. The total time of inhalation of a hypoxic gas mixture during one procedure is 20-30 minutes.
Intermittent hypoxic-hyperoxic training/controlProcedure or surgery
IHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019).
A control group of 30 patients will undergo a simulated IHHT course (with the same "exposure" time and number of sessions as intervention group - 15 sessions, 40-minutes long each, 5 workouts per week for 3 weeks). Patients of this group will breathe normoxic gas mixture (ordinary humidified air is supplied through the mask) during the entire session.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study. Receives: Procedure: Intermittent hypoxic-hyperoxic training |
| control group | Placebo comparator | The patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study. Receives: Procedure: Intermittent hypoxic-hyperoxic training/control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the levels of proinflammatory cytokines.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of proinflammatory cytokines such as Interleukin-1, Interleukin-6, Interleukin-18 and Tumor necrosis factor.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change of the endothelial function
This outcome will be assessed via taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of endothelin-1 and nitric oxide.
Measurement of endothelial function will be done by using Flow Mediated Dilation (FMD). The technique involves ultrasound measurement of arterial dilation in response to a 5-minute occlusion of the brachial artery with a blood pressure cuff.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Changes in indicators of diastolic dysfunction.
This outcome will be assessed via transthoracic echocardiography (EchoCG). Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler.
Diastolic function of the left ventricle will be assessed using pulse-wave, constant-wave, and tissue Doppler studies.
Received data will be compared to the initial one before the IHHT sessions started and the conclusion about diastolic dysfunction will be made.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Secondary outcomes (6)
Change in exercise tolerance after intermittent hypoxic-hyperoxic training.
Exercise tolerance will be determined via using a six-minute walk test . The six-minute walk test will measure the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in maximum level of oxygen consumption after intermittent hypoxic-hyperoxic training.
Exercise tolerance will be determined via using a spiroergometry to determine the patient's oxygen consumption.
The spiroergometric test will be performed under continuous stepwise increasing load.
The duration of each load step is 5 min; the initial load level is 25 W, followed by an increase in load at each step by the same amount.
The results of the test will be used to evaluate the achievement of the maximum level of oxygen consumption (in l/min or ml/min/kg body weight).
Received data will be compared to the initial one before the IHHT sessions started and the conclusion will be made.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of ferritin.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of long-term inflammatory markers such as ferritin.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of C-reactive protein.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of long-term inflammatory markers such as C-reactive protein.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of D-dimer.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of long-term inflammatory markers such as D-dimer.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of fibrinogen.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of long-term inflammatory markers such as fibrinogen.
Measured: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 Dec 2021
- Primary completion31 Dec 2023
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philipp Kopylov, Principal investigator, I.M. Sechenov First Moscow State Medical University (Sechenov University)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379608
- Sponsor's protocol ID
- AB -1771
- Status last verified
- Nov 2023
- First submitted
- 30 Apr 2022
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, as it is prohibited by Local Ethics Committee of I.M. Sechenov First Moscow State Medical University. Any necessary information may be provided after official request to Study Principal Investigator
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxic-hyperoxic Training for the Rehabilitation in Patients With Cardiovascular Pathology After COVID-19 Infection.
- ClinicalTrials.gov ID
- NCT05379608
- Acronym / sponsor ID
- AB -1771
- Conditions
- COVID-19, Chronic Heart Failure, Hypertension, Arrhythmia, Conduct Disorder, Chronic Coronary Syndrome
- Keywords
- COVID-19, inflammation, intermittent hypoxic-hyperoxic training, markers of inflammation, flow mediated dilatation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 18 May 2022 (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.
Aim of this prospective, interventional, single-center, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training (IHHT) as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection.
The study will include 60 patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University. The patients will be divided into 2 groups (intervention and control groups).
Intervention group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2 5 times a week for 3 weeks, while control group will undergo a simulated IHHT.
All the patients will undergo identical laboratory and instrumental testing before IHHT, after the last IHHT procedure, in a month after the last IHHT procedure and in 6 months.
Estimated result of the study is to confirm or refute the hypothesis of the study that a three-week course of IHHT in patients with cardiovascular pathology in the early period after coronavirus infection can improve exercise tolerance, as well as the quality of life and psychoemotional status, and affect the dynamics of laboratory and instrumental parameters.
Detailed description
Aim of this prospective, interventional, single-centered, randomized study is to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training as a rehabilitation method in patients with cardiovascular pathology in the early period after coronavirus infection.
The study will include 60 patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection (polymerase chain reaction (PCR) testing, enzyme-linked immunosorbent assay (positive result at least 1 time)) 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University.
Patients will be randomized via the random number table method into two groups, comparable by gender, age and comorbidity:
Intermittent hypoxic-hyperoxic training (intervention group) group, 30 patients who will receive 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks. Patients in the IHHT group will inhale hypoxic gas mixtures (10-12% O2) followed by exposure to a hyperoxic gas mixture with 30-35% O2.
A control group of 30 patients will undergo a simulated IHHT course with the same "exposure" time and number of sessions. Patients of this group will breathe normoxic gas mixture using the same equipment; ordinary humidified air is supplied through the mask during the entire session.
Patients eligible for inclusion will undergo the following investigations:
- Anamnesis and complaints collection; physical examination;
- Assessment of the quality of life and psycho-emotional status using the Short Form-36 (SF36) and Hospital Anxiety and Depression Scale (HADS) questionnaires, as well as the six-minute walk test;
- General and biochemical blood tests , urine analysis, , determination of markers of inflammation (ferritin, C-reactive protein, D-dimer, fibrinogen, interleukin-1, interleukin-6, interleukin-18 and tumor necrosis factor), the level of Endothelin-1 and nitric oxide (NO) in the blood;
- Electrocardiography, a flow mediated dilatation procedure for endothelial function assessment,transthoracic echocardiography to identify the structural and functional features of the myocardium, spiroergometry to determine the patient's oxygen consumption.
The statistical processing will be performed using the Python Software Foundation version 3.8 for Windows (Delaware, USA).
Estimated result of the study is to confirm or refute the hypothesis of the study that a three-week course of IHHT in patients with cardiovascular pathology in the early stages after suffering a coronavirus infection can improve exercise tolerance, as well as the quality of life and psychoemotional status, and affect the dynamics of laboratory and instrumental parameters.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Procedure: Intermittent hypoxic-hyperoxic trainingThe patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study. |
| control group | Placebo comparator | Procedure: Intermittent hypoxic-hyperoxic training/controlThe patients with cardiovascular pathology who underwent confirmed by laboratory tests COVID-19 infection 1-3 months ago with the degree of lung lesion CT3, CT4, who were admitted to the University Clinical Hospital No. 4 of I.M. Sechenov First Moscow State Medical University will be included in the study. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Written informed consent to participate in the study;
- Age 40 and over;
- Male and female;
- One or more cardiovascular pathologies in the anamnesis:
- COVID-19 infection confirmed by laboratory tests (polymerase chain reaction testing, enzyme-linked immunosorbent assay (positive result at least 1 time) with a CT degree of 3 or higher.
Key exclusion criteria (3 listed)
- Refusal to further participation in the study;
- Acute psychotic reactions arising in the process of the study;
- Exacerbation of chronic diseases, requiring a change in patient management tactics and preventing his or her further 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent hypoxic-hyperoxic trainingIHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019). Each patient will undergo a hypoxic test to assess the individual response to hypoxia. The minimum safe SpO2 value is 82%, and the maximum allowable heart rate increase during exercise is + 50% of the starting value. When these parameters are reached, an automatic switch to the supply of a hyperoxic gas mixture (35-40% oxygen) occurs till the SpO2 level is 100%. During each training session a hypoxic gas mixture is supplied to the patient in an intermittent mode, alternating with the supply of a hyperoxic gas mixture. On average, each workout includes 6 of the above cycles. The total time of inhalation of a hypoxic gas mixture during one procedure is 20-30 minutes. | Procedure or surgery | intervention group |
| Intermittent hypoxic-hyperoxic training/controlIHHT will be carried out using the ReOxy normobaric hypoxic therapy apparatus (Bitmos GmbH, Germany, 26790/10221, 04/10/2019). A control group of 30 patients will undergo a simulated IHHT course (with the same "exposure" time and number of sessions as intervention group - 15 sessions, 40-minutes long each, 5 workouts per week for 3 weeks). Patients of this group will breathe normoxic gas mixture (ordinary humidified air is supplied through the mask) during the entire session. | Procedure or surgery | control group |
Primary outcome
Change in the levels of proinflammatory cytokines.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
This outcome will be assessed by taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of proinflammatory cytokines such as Interleukin-1, Interleukin-6, Interleukin-18 and Tumor necrosis factor.
Change of the endothelial function
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
This outcome will be assessed via taking blood samples from a peripheral vein before and after IHHT to determine and compare the levels of endothelin-1 and nitric oxide. Measurement of endothelial function will be done by using Flow Mediated Dilation (FMD). The technique involves ultrasound measurement of arterial dilation in response to a 5-minute occlusion of the brachial artery with a blood pressure cuff.
Changes in indicators of diastolic dysfunction.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
This outcome will be assessed via transthoracic echocardiography (EchoCG). Transthoracic EchoCG will be performed to assess the heart structure and function: unidimensional (M-mode), two-dimensional (B-mode) and Doppler. Diastolic function of the left ventricle will be assessed using pulse-wave, constant-wave, and tissue Doppler studies. Received data will be compared to the initial one before the IHHT sessions started and the conclusion about diastolic dysfunction will be made.
6 secondary outcomes
Change in exercise tolerance after intermittent hypoxic-hyperoxic training.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in maximum level of oxygen consumption after intermittent hypoxic-hyperoxic training.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of ferritin.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of C-reactive protein.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of D-dimer.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
Change in the levels of fibrinogen.
Time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.
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 11 Jul 2025.
- Individual participant dataSharing planned: No. No, as it is prohibited by Local Ethics Committee of I.M. Sechenov First Moscow State Medical University. Any necessary information may be provided after official request to Study Principal Investigator
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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.
Philipp Kopylov principal investigator
I.M. Sechenov First Moscow State Medical University (Sechenov University)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent hypoxic-hyperoxic training in people with COVID-19 and Chronic Heart Failure, run by I.M. Sechenov First Moscow State Medical University at 1 site 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 29 inclusion and 3 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 11 Jul 2025. 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 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. 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?
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?
Change in the levels of proinflammatory cytokines. (time frame: In 6 months after the reception of 15 IHHT sessions, 40-minutes long each (5 workouts per week) for 3 weeks.). The study lists 3 primary outcomes in all. 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 11 Jul 2025.