Intermittent hypoxic-hyperoxic training for heart patients after COVID-19

Intermittent Hypoxic-hyperoxic Training for the Rehabilitation in Patients With Cardiovascular Pathology After COVID-19 Infection.

This study is testing whether a special breathing exercise called intermittent hypoxic-hyperoxic training can help heart patients recover better after having COVID-19.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 40 Years to 75 Years
• Sex: All
• Sponsor: I.M. Sechenov First Moscow State Medical University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Moscow)
• Trial ID: NCT05379608 on ClinicalTrials.gov

What this trial studies

This interventional study aims to evaluate the efficacy and safety of intermittent hypoxic-hyperoxic training (IHHT) as a rehabilitation method for patients with cardiovascular issues following COVID-19 infection. It will involve 60 patients who have experienced confirmed COVID-19 and have cardiovascular pathologies, dividing them into an intervention group receiving IHHT and a control group undergoing simulated IHHT. The intervention group will inhale hypoxic gas mixtures followed by hyperoxic gas mixtures over a series of sessions, while both groups will undergo similar assessments before and after the treatment. The study seeks to determine the impact of IHHT on cardiovascular recovery in these patients.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40 and over with confirmed cardiovascular pathologies who have recovered from COVID-19.

Not a fit: Patients without cardiovascular issues or those who are not within the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance rehabilitation outcomes for patients with cardiovascular conditions post-COVID-19.

How similar studies have performed: While the specific approach of IHHT is novel, similar rehabilitation methods have shown promise in improving cardiovascular health in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent to participate in the study;
2. Age 40 and over;
3. Male and female;
4. 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.
5. 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:

1. Acute infectious diseases, tuberculosis;
2. Chronic somatic diseases in the acute stage;
3. Congenital anomalies of the heart and large vessels;
4. Valvular heart defects (congenital and acquired);
5. Severe atherosclerosis of the lower extremities'vessels (chronic ischemia of the lower extremities,stage 3-4);
6. Acute decompensated heart failure (II-IV class according to Killip classification);
7. Chronic heart failure IV functional class (New York Heart Association Functional Classification classification);
8. Secondary arterial hypertension;
9. Acute coronary syndrome within 4 weeks before the start of the study;
10. Life-threatening rhythm and conduction disturbances;
11. Bronchial asthma with the development of respiratory failure II-III degree;
12. Acute cerebrovascular accident within the last 4 months;
13. Chronic kidney disease (glomerular filtration rate\<30 ml / min / 1.73 m2 via CKD-EPI (chronic kidney disease epidemiology collaboration) formula);
14. Pregnancy;
15. Mental illness (severe dementia, schizophrenia, severe depression, manic-depressive psychosis);
16. Oncology, diagnosed within a year or receiving a course of radiation / chemotherapy for cancer at the present time;
17. Severe cognitive impairment (MOS) and clinically significant anxiety and / or depression (HADS) interfering with observation;
18. Individual intolerance to oxygen deficiency.

Exclusion Criteria:

1. Refusal to further participation in the study;
2. Acute psychotic reactions arising in the process of the study;
3. Exacerbation of chronic diseases, requiring a change in patient management tactics and preventing his or her further participation in the study.

Where this trial is running

Moscow

• 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, Russian Federation (Recruiting)

Study contacts

• Principal investigator: Philipp Kopylov — I.M. Sechenov First Moscow State Medical University (Sechenov University)
• Study coordinator: Philipp Kopylov

Conditions COVID-19; Chronic Heart Failure; Hypertension; Arrhythmia; Conduct Disorder; Chronic Coronary Syndrome; Endothelial Dysfunction; Diastolic Dysfunction