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ACTIVE NOT RECRUITING

NCT07075835

Enhanced External Counterpulsation for Patients With Ventilation Disorders

Sponsor: I.M. Sechenov First Moscow State Medical University

View on ClinicalTrials.gov

Summary

This study evaluates enhanced external counterpulsation as a non-pharmacological therapy for patients with severe and moderate ventilation disorders due to chronic lung diseases (chronic obstructive pulmonary disease, bronchial asthma and interstitial lung diseases). The study will include 80 patients with severe (30% \< forced expiratory volume in 1 second \< 49% or lung diffusion capacity \< 40%) and moderate (50% \< forced expiratory volume in 1 second \< 59% or lung diffusion capacity 40-60%) ventilation disorders, who will be divided into 2 groups (the main group and the comparison group). In addition to optimal pharmacological therapy according to the current clinical guidelines of the Russian Ministry of Health, the main group will receive a course of enhanced external counterpulsation. The comparison group will receive only optimal pharmacological therapy (according to the current clinical guidelines of the Russian Ministry of Health). At the time of inclusion in the study and after 1 month, spirometry, bodyplethysmography, lung diffusion capacity, a 6-minute walk test and an assessment of quality of life according to the SF-36 questionnaire will be conducted.

Official title: Enhanced External Counterpulsation as a Non-pharmacological Treatment for Patients With Severe and Moderate Ventilation Disorders

Key Details

Gender

All

Age Range

35 Years - 74 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-11-01

Completion Date

2027-07-01

Last Updated

2025-08-11

Healthy Volunteers

Conditions

Chronic Lung Diseases

Interventions

PROCEDURE

Enhanced external counterpulsation

20 (5 days a week for 4 weeks) one-hour procedures (compression pressure 220-280 mmHg) of enhanced external counterpulsation (device: LUMENAIR EECP, Vasomedical Inc., USA, registration certificate №2018/6915 dated 15.03.2018). The systolic deflation/diastolic inflation sequence of enhanced external counterpulsation leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries.

Inclusion Criteria: * Verified severe (30% \< forced expiratory volume in 1 second \< 49% or lung diffusion capacity \< 40%) and moderate (50% \< forced expiratory volume in 1 second \< 59% or lung diffusion capacity 40-60%) ventilation disorders in patients with different chronic lung diseases who are on optimal basic therapy (according to current clinical guidelines) and are in a stable state of respiratory disease (1 month without exacerbations) * Signed informed voluntary consent to participate in the study Exclusion Criteria: * A history of thrombophlebitis and/or phlebitis * Thoracic or abdominal aortic aneurysm * Severe pathology of the valvular heart (Area of orifice in stenoses: Aortic and tricuspid valves: \< 1.0 cm²; Mitral valve: \< 1.5 cm². Pulmonary valve: pressure gradient between right ventricle and pulmonary artery \> 50 mmHg; In case of insufficiency, regurgitation of grade 3-4 according to echocardiography) * Pregnancy * High pulmonary hypertension (grade 2-3; \>45 mmHg) * Catheterization cardiac arrest performed within 2-4 weeks before the study * Tachyarrhythmias (device Myocard-12) * Uncontrolled arterial hypertension (\>180/110 mmHg when treated with 3 drugs, one of which is a diuretic) * Hemorrhagic conditions critical arterial ischemia of the lower extremities (Stages 3 and 4 of chronic arterial insufficiency of the lower extremities according to the Pokrovsky-Fontaine classification are patients with pain at rest and with trophic or infectious-inflammatory changes in the tissues of the extremities * Dilatation of the heart cavities (device Philips iU22 Ultrasound) * Ejection fraction \<50% (device Philips iU22 Ultrasound) * Level of NT-pro BNP \> 125 pg/ml * A history of myocardial infarction * Severe renal (glomerular filtration rate \<30 ml/min/1,73 m2) failure * Hepatic failure (B and C on the Child-Pugh scale) * Poor tolerance of the procedure (side effects that disrupt the patient's condition and prevent the continuation of procedures (local: hyperemia, pain, and itching in the area of the cuff application; systemic: hypertensive reaction, dizziness) * Low patient compliance (skipping more than 3 procedures), refusal to participate in the study * Exacerbation of the underlying disease during the study

Locations (1)

Department of Pulmonology, Clinical Hospital No. 1, I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University).

Moscow, Russia