Status:
COMPLETED
Intermittent Hypoxic-hyperoxic Training in Patients With Cardiovascular Pathology After COVID-19 Infection.
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
COVID-19
Chronic Heart Failure
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- 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);
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05379608
Start Date
December 10 2021
End Date
April 30 2025
Last Update
July 11 2025
Active Locations (1)
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1
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, Russia, 119435