Long-tErm Effects of Enhanced eXternal CountErpuLsation
NCT ID: NCT05913778
Last Updated: 2025-04-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-12-10
Study Completion Date
2025-01-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Enhanced external counterpulsation (EECP) is an effective non-invasive treatment in patients with coronary artery disease (CAD) which complicated by chronic heart failure (CHF).
Aim: to study the long-term effects of treatment with enhanced external counterpulsation on the structural and functional state of the vascular bed in patients with stable CAD complicated by CHF.
Patients (n=100) with verified stable CAD (class 2-3 angina) complicated by CHF (NYHA class 2-3) and receiving optimal drug therapy included in open randomized study.
Primary randomization (2:1) + secondary randomization (1:1).
* SHAM-counterpulsation group (ECP-SHAM; compression pressure 80 mm Hg; 35 procedures, 1 hour each);
* Active counterpulsation group (ECP35; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 1 course per year;
* Active counterpulsation group (ECP70; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 2 courses per year.
Duration of observation is 3 years. Stages of examination: after 3, 6, 12, 24, 36 months (after 3, 6, 12 months for the ECP-SHAM group).
Primary endpoint: combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death.
Secondary endpoints: changes in exercise tolerance, a needing for antianginal therapy, frequency of angina episodes.
Objectives: to study the dynamics of the structural and functional state of the vascular bed (applanation tonometry, photoplethysmography, computer nailfold videocapillaroscopy), the dynamics of the clinical status (Clinical Status Assessment Scale), the dynamics of exercise tolerance (6-minute walk test), the dynamics of the quality of life of patients ( questionnaires SF36 and MLHFQ) in the ECP35 and ECP70 groups at baseline, at the end of the first course, after 6 months, 1, 2, and 3 years, and in the ECPSHAM group at baseline, at the end of the first course, after 6 and 12 months; (2) To investigate the impact of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, death) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints.
Expected outcome of the study: Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional state of the vascular bed, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF.
Aim: to study the long-term effects of treatment with enhanced external counterpulsation on the structural and functional state of the vascular bed in patients with stable CAD complicated by CHF.
Patients (n=100) with verified stable CAD (class 2-3 angina) complicated by CHF (NYHA class 2-3) and receiving optimal drug therapy included in open randomized study.
Primary randomization (2:1) + secondary randomization (1:1).
* SHAM-counterpulsation group (ECP-SHAM; compression pressure 80 mm Hg; 35 procedures, 1 hour each);
* Active counterpulsation group (ECP35; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 1 course per year;
* Active counterpulsation group (ECP70; compression pressure 220-280 mm Hg; 35 procedures, 1 hour each) 2 courses per year.
Duration of observation is 3 years. Stages of examination: after 3, 6, 12, 24, 36 months (after 3, 6, 12 months for the ECP-SHAM group).
Primary endpoint: combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death.
Secondary endpoints: changes in exercise tolerance, a needing for antianginal therapy, frequency of angina episodes.
Objectives: to study the dynamics of the structural and functional state of the vascular bed (applanation tonometry, photoplethysmography, computer nailfold videocapillaroscopy), the dynamics of the clinical status (Clinical Status Assessment Scale), the dynamics of exercise tolerance (6-minute walk test), the dynamics of the quality of life of patients ( questionnaires SF36 and MLHFQ) in the ECP35 and ECP70 groups at baseline, at the end of the first course, after 6 months, 1, 2, and 3 years, and in the ECPSHAM group at baseline, at the end of the first course, after 6 and 12 months; (2) To investigate the impact of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, death) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints.
Expected outcome of the study: Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional state of the vascular bed, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treating Heart Failure With Enhanced External Counterpulsation (EECP)
NCT03021213
Heart Failure
WITHDRAWN
A Study to Evaluate the Effects of EECP in Patients With Heart Failure
NCT03857022
Heart Failure
UNKNOWN
NA
DevElopMent of Clinical PATHwaYs to the Diagnosis of Heart Failure With Preserved Ejection Fraction
NCT05792059
Heart Failure With Preserved Ejection Fraction (HFpEF)
UNKNOWN
SPECT-based Prediction and Evaluation of CRT Efficacy in CHF
NCT03667989
Chronic Heart Failure
COMPLETED
NA
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
NCT00303979
Heart Failure, Congestive
Myocardial Infarction
Ventricular Dysfunction, Left
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Topic relevance
The dominant positions of coronary artery disease (CAD) in the structure of morbidity, disability and mortality among patients with cardiovascular diseases determine the social significance of this disease. With an increase in the incidence of cardiovascular diseases from 2.483 million cases in 2000 to 4.784 million cases in 2018 (an increase of 193%), there is also an increase in newly diagnosed cases of CAD by 47%. The mortality rate from circulatory diseases in Russia over the past 15 years has decreased from 927.5 to 587.6 per 100,000 population. Achievements of modern medicine (optimization of pharmacotherapy and an increase in the number of revascularization procedures) have contributed to an improvement in the survival rates of patients with CAD. However, with an increase in life expectancy, the economic burden of atherosclerotic diseases and the need to improve the quality of life of such patients increase.
Taking into account the insufficient effect of a conservative strategy in patients with severe stenoses in the coronary bed, a clear increase in the number of revascularization procedures has been observed over the past two decades. However, the limited duration of the effective functioning of stents and shunts, as well as the lack of proven benefits in terms of influencing the prognosis compared to conservative measures do not allow to fully rely on this strategy as well. In the population, there is an accumulation of the proportion of people with refractory angina pectoris, with insufficient effectiveness of the use of conservative and invasive strategies. The basis of this population is patients with progression of multivessel coronary atherosclerosis, microvascular disease, incomplete myocardial revascularization, stenosis or occlusion of shunts / stents, and patients who cannot undergo coronary bypass surgery or stenting, including repeated ones, for various other reasons. In addition, the course of coronary artery disease in such patients is often complicated by chronic heart failure (CHF), which further reduces the quality of life of patients and the prognosis. This determines the search for additional methods of treatment for these patients, which can enhance the effect of conservative and invasive strategies.
Enhanced external counterpulsation (EECP) is an effective non-invasive and atraumatic treatment for patients with coronary artery disease, including complicated CHF. Preference should be given to this method in patients with severe diffuse lesions of the coronary arteries, in case of impossibility or high risk of myocardial revascularization, as well as in case of complication of heart failure. The influence of this method on the contractility of the heart, exercise tolerance and quality of life of these patients has been studied quite well. However, the long-term effects of EECP on the structural and functional state of the vascular bed (the main targets of this method) in patients with coronary artery disease complicated by CHF remain little studied.
2. The novelty of the proposed topic on literary sources and patent documentation. No similarly designed studies were found in the available literature. Scientific novelty It is planned to study long-term vascular effects, the impact on exercise tolerance, quality of life, the frequency of serious adverse events, the impact on the prognosis during the treatment of EECP patients with stable CAD complicated by CHF. It is planned to expand the possible indications for EECP, optimize the treatment of EECP in patients with refractory angina and heart failure.
3. Purpose and objectives of the planned research. Purpose of the study - To study the long-term effects of treatment with EECP on the structural and functional vascular state in patients with stable CAD complicated by CHF.
Research objectives.
• To study the dynamics of the structural and functional vascular state (applanation tonometry, photoplethysmography, computer nailfold capillaroscopy) in active EECP groups (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, according to at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
• To study the dynamics of the clinical status (Clinical State Assessment Scale) in the groups of active EECP (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
• To study the dynamics of exercise tolerance (6-minute walk test) in active EECP groups (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
* To study the dynamics of the quality of life of patients (SF36 and MLHFQ questionnaires) in the groups of active EECP (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year through the baseline, at the end of the course, 6 months, 1 , 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
* To study the dynamics of the frequency of angina pectoris episodes, the need for antianginal drugs, the frequency of vascular events, hospitalizations (for coronary artery disease / CHF), deaths in active EECP groups (220-280 mm Hg, 35 procedures) for 2 or 1 course per year and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) during the observation period.
* To study the effect of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, deaths) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints;
* Perform a correlation analysis between EECP treatment parameters (number of procedures and duration of treatment) with the characteristics under study (vascular and clinical effects).
4. Planned type of scientific research The study is open, prospective, randomized, controlled in parallel groups.
5. Object of study and the planned number of observations. The object of the study were patients (n=100) with verified CAD (class 2-3, stable angina), complicated by CHF (NYHA class 2-3), receiving optimal drug therapy.
Inclusion Criteria:
* Age 40-75 years
* Verified CAD (class 2-3, stable angina) complicated by CHF (NYHA class 2-3)
* Signed voluntary informed consent to participate in the study
Non-inclusion/exclusion criteria:
* Contraindications to treatment with EECP: recent (2-4 weeks ago) catheterization of arterial vessels; cardiac arrhythmias that can affect the synchronization of counterpulsation with the ECG; decompensated heart failure; left ventricular ejection fraction less than 30%; severe aortic insufficiency; critical ischemia of the arteries of the lower extremities; thrombosis / thrombophlebitis of the veins of the lower extremities; uncontrolled arterial hypertension (\>180/110mm Hg); high pulmonary hypertension (grade 2-3; \>45 mm Hg); coagulopathy, treatment with anticoagulants with prothrombin time \>15 sec/INR \>3; pregnancy; aneurysm of the thoracic or abdominal aorta requiring surgical treatment.
* Refusal of the patient from further participation in the study.
6\. Specific methods of the planned research
(1) Clinical analysis of present symptoms. (2) General clinical examination, including laboratory research methods (general blood count, general urinalysis, biochemical blood test) and instrumental studies (electrocardiography, echocardiography, daily ECG monitoring, ultrasound of the vessels of the lower extremities).
(3) Assessment of exercise tolerance (6-minute walk test). (4) Evaluation of the functional status (Scale for Assessment of the Clinical State as modified by V.Yu. Mareev).
(5) Quality of life assessment: Questionnaire SF-36 (The Short Form-36); MLHFQ (Minnesota Living With Heart Failure Questionnaire; Minnesota Living With Heart Failure Questionnaire).
(6) Non-invasive vascular examination: assessment of remodeling of the microvasculature: computer nailfold capillaroscopy (Capillaroscan-1, Russia); determination of the structural and functional state of the walls of large vessels and microvasculature: photoplethysmography (Angioscan-01, Russia); determination of the level of central arterial pressure, augmentation index: applanation tonometry (A-pulse CASPro, USA).
(7) The study of patients' self-monitoring diaries (frequency of angina episodes, need for antianginal drugs), the frequency of hospitalizations for coronary artery disease/CHF, the frequency of vascular events/revascularizations.
7\. The expected result of the study. Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional vascular state, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF. To substantiate the wider inclusion of treatment with EECP in a comprehensive program for the management of patients with CAD, including complicated CHF, along with a conservative and invasive strategy, to optimize the treatment with EECP in these patients. Presentation of the results obtained in the form of publications and implementation of the results in practical healthcare (expansion of indications for the treatment of EECP; reference to training programs for doctors).
8\. Base of scientific research. Department of Hospital Therapy No. 1, First Moscow State Medical University. THEM. Sechenov (University Clinical Hospital No. 1, First Moscow State Medical University named after I.M. Sechenov).
9\. Calendar terms of performance of work:
1. Beginning of material collection December 2020
2. Completion of the collection of material December 2021
The dominant positions of coronary artery disease (CAD) in the structure of morbidity, disability and mortality among patients with cardiovascular diseases determine the social significance of this disease. With an increase in the incidence of cardiovascular diseases from 2.483 million cases in 2000 to 4.784 million cases in 2018 (an increase of 193%), there is also an increase in newly diagnosed cases of CAD by 47%. The mortality rate from circulatory diseases in Russia over the past 15 years has decreased from 927.5 to 587.6 per 100,000 population. Achievements of modern medicine (optimization of pharmacotherapy and an increase in the number of revascularization procedures) have contributed to an improvement in the survival rates of patients with CAD. However, with an increase in life expectancy, the economic burden of atherosclerotic diseases and the need to improve the quality of life of such patients increase.
Taking into account the insufficient effect of a conservative strategy in patients with severe stenoses in the coronary bed, a clear increase in the number of revascularization procedures has been observed over the past two decades. However, the limited duration of the effective functioning of stents and shunts, as well as the lack of proven benefits in terms of influencing the prognosis compared to conservative measures do not allow to fully rely on this strategy as well. In the population, there is an accumulation of the proportion of people with refractory angina pectoris, with insufficient effectiveness of the use of conservative and invasive strategies. The basis of this population is patients with progression of multivessel coronary atherosclerosis, microvascular disease, incomplete myocardial revascularization, stenosis or occlusion of shunts / stents, and patients who cannot undergo coronary bypass surgery or stenting, including repeated ones, for various other reasons. In addition, the course of coronary artery disease in such patients is often complicated by chronic heart failure (CHF), which further reduces the quality of life of patients and the prognosis. This determines the search for additional methods of treatment for these patients, which can enhance the effect of conservative and invasive strategies.
Enhanced external counterpulsation (EECP) is an effective non-invasive and atraumatic treatment for patients with coronary artery disease, including complicated CHF. Preference should be given to this method in patients with severe diffuse lesions of the coronary arteries, in case of impossibility or high risk of myocardial revascularization, as well as in case of complication of heart failure. The influence of this method on the contractility of the heart, exercise tolerance and quality of life of these patients has been studied quite well. However, the long-term effects of EECP on the structural and functional state of the vascular bed (the main targets of this method) in patients with coronary artery disease complicated by CHF remain little studied.
2. The novelty of the proposed topic on literary sources and patent documentation. No similarly designed studies were found in the available literature. Scientific novelty It is planned to study long-term vascular effects, the impact on exercise tolerance, quality of life, the frequency of serious adverse events, the impact on the prognosis during the treatment of EECP patients with stable CAD complicated by CHF. It is planned to expand the possible indications for EECP, optimize the treatment of EECP in patients with refractory angina and heart failure.
3. Purpose and objectives of the planned research. Purpose of the study - To study the long-term effects of treatment with EECP on the structural and functional vascular state in patients with stable CAD complicated by CHF.
Research objectives.
• To study the dynamics of the structural and functional vascular state (applanation tonometry, photoplethysmography, computer nailfold capillaroscopy) in active EECP groups (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, according to at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
• To study the dynamics of the clinical status (Clinical State Assessment Scale) in the groups of active EECP (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
• To study the dynamics of exercise tolerance (6-minute walk test) in active EECP groups (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year initially, at the end of the course, after 6 months, 1, 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
* To study the dynamics of the quality of life of patients (SF36 and MLHFQ questionnaires) in the groups of active EECP (220-280 mm Hg; 35 procedures) 2 courses per year or 1 course per year through the baseline, at the end of the course, 6 months, 1 , 2 and 3 years and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) at baseline, at the end of the course, after 6 and 12 months;
* To study the dynamics of the frequency of angina pectoris episodes, the need for antianginal drugs, the frequency of vascular events, hospitalizations (for coronary artery disease / CHF), deaths in active EECP groups (220-280 mm Hg, 35 procedures) for 2 or 1 course per year and in the SHAM external counterpulsation group (placebo; 80 mm Hg; 35 procedures) during the observation period.
* To study the effect of EECP on the incidence of primary (vascular events, hospitalizations for CAD/CHF, deaths) and secondary (frequency of angina episodes, need for antianginal drugs, exercise tolerance) endpoints;
* Perform a correlation analysis between EECP treatment parameters (number of procedures and duration of treatment) with the characteristics under study (vascular and clinical effects).
4. Planned type of scientific research The study is open, prospective, randomized, controlled in parallel groups.
5. Object of study and the planned number of observations. The object of the study were patients (n=100) with verified CAD (class 2-3, stable angina), complicated by CHF (NYHA class 2-3), receiving optimal drug therapy.
Inclusion Criteria:
* Age 40-75 years
* Verified CAD (class 2-3, stable angina) complicated by CHF (NYHA class 2-3)
* Signed voluntary informed consent to participate in the study
Non-inclusion/exclusion criteria:
* Contraindications to treatment with EECP: recent (2-4 weeks ago) catheterization of arterial vessels; cardiac arrhythmias that can affect the synchronization of counterpulsation with the ECG; decompensated heart failure; left ventricular ejection fraction less than 30%; severe aortic insufficiency; critical ischemia of the arteries of the lower extremities; thrombosis / thrombophlebitis of the veins of the lower extremities; uncontrolled arterial hypertension (\>180/110mm Hg); high pulmonary hypertension (grade 2-3; \>45 mm Hg); coagulopathy, treatment with anticoagulants with prothrombin time \>15 sec/INR \>3; pregnancy; aneurysm of the thoracic or abdominal aorta requiring surgical treatment.
* Refusal of the patient from further participation in the study.
6\. Specific methods of the planned research
(1) Clinical analysis of present symptoms. (2) General clinical examination, including laboratory research methods (general blood count, general urinalysis, biochemical blood test) and instrumental studies (electrocardiography, echocardiography, daily ECG monitoring, ultrasound of the vessels of the lower extremities).
(3) Assessment of exercise tolerance (6-minute walk test). (4) Evaluation of the functional status (Scale for Assessment of the Clinical State as modified by V.Yu. Mareev).
(5) Quality of life assessment: Questionnaire SF-36 (The Short Form-36); MLHFQ (Minnesota Living With Heart Failure Questionnaire; Minnesota Living With Heart Failure Questionnaire).
(6) Non-invasive vascular examination: assessment of remodeling of the microvasculature: computer nailfold capillaroscopy (Capillaroscan-1, Russia); determination of the structural and functional state of the walls of large vessels and microvasculature: photoplethysmography (Angioscan-01, Russia); determination of the level of central arterial pressure, augmentation index: applanation tonometry (A-pulse CASPro, USA).
(7) The study of patients' self-monitoring diaries (frequency of angina episodes, need for antianginal drugs), the frequency of hospitalizations for coronary artery disease/CHF, the frequency of vascular events/revascularizations.
7\. The expected result of the study. Obtaining reliable data on the long-term positive effect of EECP on the dynamics of the structural and functional vascular state, exercise tolerance, quality of life and prognosis in patients with stable CAD complicated by CHF. To substantiate the wider inclusion of treatment with EECP in a comprehensive program for the management of patients with CAD, including complicated CHF, along with a conservative and invasive strategy, to optimize the treatment with EECP in these patients. Presentation of the results obtained in the form of publications and implementation of the results in practical healthcare (expansion of indications for the treatment of EECP; reference to training programs for doctors).
8\. Base of scientific research. Department of Hospital Therapy No. 1, First Moscow State Medical University. THEM. Sechenov (University Clinical Hospital No. 1, First Moscow State Medical University named after I.M. Sechenov).
9\. Calendar terms of performance of work:
1. Beginning of material collection December 2020
2. Completion of the collection of material December 2021
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Coronary Artery Disease
Chronic Heart Failure
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
open, prospective, randomized, controlled in parallel groups
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Enhanced external counterpulsation 35 hours per year
Subjects with Heart failure with Enhanced external counterpulsation therapy (inflation pressure 220-280 mm Hg; 35 procedures) was given as a 1-hour session, once daily, for a total of 35 sessions, 1 course per 12 months
Group Type
EXPERIMENTAL
Enhanced external counterpulsation
Intervention Type
DEVICE
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries.
Enhanced external counterpulsation 70 hours per year
Subjects with Heart failure with Enhanced external counterpulsation therapy (inflation pressure 220-280 mm Hg; 35 procedures) was given as a 1-hour session, once daily, for a total of 35 sessions, 1 course per 6 months
Group Type
EXPERIMENTAL
Enhanced external counterpulsation
Intervention Type
DEVICE
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries.
SHAM external counterpulsation
Subjects with Heart failure with SHAM external counterpulsation (inflation pressure 80 mm Hg; 35 procedures) was given as a 1-hour session, once daily, for a total of 35 sessions, 1 course per 12 months
Group Type
SHAM_COMPARATOR
Enhanced external counterpulsation
Intervention Type
DEVICE
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Enhanced external counterpulsation
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner in coronary artery and in others organ arteries.
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
EECP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 40-75 years
* Verified CAD (class 2-3, stable angina) complicated by CHF (NYHA class 2-3)
* Optimal medical treatment
* Signed voluntary informed consent to participate in the study
* Verified CAD (class 2-3, stable angina) complicated by CHF (NYHA class 2-3)
* Optimal medical treatment
* Signed voluntary informed consent to participate in the study
Exclusion Criteria
* Contraindications to treatment with EECP: recent (2-4 weeks ago) catheterization of arterial vessels; cardiac arrhythmias that can affect the synchronization of counterpulsation with the ECG; decompensated heart failure; left ventricular ejection fraction less than 30%; severe aortic insufficiency; critical ischemia of the arteries of the lower extremities; thrombosis / thrombophlebitis of the veins of the lower extremities; uncontrolled arterial hypertension (\>180/110mm Hg); high pulmonary hypertension (grade 2-3; \>45 mm Hg); coagulopathy, treatment with anticoagulants with prothrombin time \>15 sec/INR \>3; pregnancy; aneurysm of the thoracic or abdominal aorta requiring surgical treatment.
* Refusal of the patient from further participation in the study.
* Refusal of the patient from further participation in the study.
Minimum Eligible Age
40 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
I.M. Sechenov First Moscow State Medical University
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexey Lishuta, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
I.M. Sechenov First Moscow State Medical University (Sechenov University)
Moscow, , Russia
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Russia
References
Explore related publications, articles, or registry entries linked to this study.
Karaganov K.S., Lishuta A.S., Belenkov Y.N. The Use of Enhanced External Counterpulsation in the Treatment of Patients with Coronary Artery Disease. Rational Pharmacotherapy in Cardiology. 2020;16(4):579-584. (In Russ.) https://doi.org/10.20996/1819-6446-2020-08-07
Reference Type
BACKGROUND
Karaganov K.S., Slepova O.A., Lishuta A.S., Solomakhina N.I., Belenkov Yu.N. Medium-term Effects of Enhanced External Counterpulsation in the Structural and Functional Parameters of Blood Vessels in Patients with Coronary Artery Disease. Rational Pharmacotherapy in Cardiology. 2021;17(4):557-563. https://doi.org/10.20996/1819-6446-2021-08-03
Reference Type
BACKGROUND
Slepova O.A., Lishuta A.S., Vasiltsova E.Yu., Privalova E.V., Belenkov Yu.N. The Effect of Enhanced External Counterpulsation on the Vascular State, Indicators of Glycemic Control and Quality of Life in Patients with Coronary Artery Disease and Type 2 Diabetes Mellitus. Rational Pharmacotherapy in Cardiology. 2022;18(3):274-281. https://doi.org/10.20996/1819-6446-2022-06-04
Reference Type
BACKGROUND
Mamieva Z.A., Lishuta A.S., Belenkov Yu.N., Privalova E.V., Yusupova A.O., Rykova S.M. POSSIBILITIES OF ENHANCED EXTERNAL COUNTERPULSATION USING IN CLINICAL PRACTICE. Rational Pharmacotherapy in Cardiology. 2017;13(2):238-247. (In Russ.) https://doi.org/10.20996/1819-6446-2017-13-2-238-247
Reference Type
BACKGROUND
Lishuta A.S., Nikolaeva N.A., Belenkov Yu.N. Long-term vascular effects of enhanced external counterpulsation in patients with coronary artery disease complicated by heart failure. Medical and pharmaceutical journal "Pulse". 2024; 26 (4): 81-89. http://dx.doi.org//10.26787/nydha-2686-6838-2024-26-4-81-89
Reference Type
RESULT
Lishuta A.S., Slepova O.A., Nikolaeva N.A., Belenkov Yu.N. Medium-term effects of enhanced external counterpulsation on markers of glycemic control in patients with chronic heart failure of ischemic genesis. Medical and pharmaceutical journal "Pulse". 2024; 26 (5): 92-99. http://dx.doi.org//10.26787/nydha-2686-6838-2024-26-5-92-99
Reference Type
RESULT
Lishuta A.S., Nikolaeva N.A., Belenkov Yu.N. Long-term effectiveness of enhanced external counterpulsation in patients with chronic heart failure of ischemic genesis. Medical and pharmaceutical journal "Pulse". 2024; 26 (6): 63-70. http://dx.doi.org//10.26787/nydha-2686-6838-2024-26-6-63-70
Reference Type
RESULT
Lishuta A.S., Slepova O.A., Nikolaeva N.A., Privalova E.V., Belenkov Yu.N. Long-term effects of enhanced external counterpulsation in the management of patients with coronary artery disease complicated by heart failure: data from the EXCEL study. Creative cardiology. 2024; 18 (2): 194-201. DOI: 10.24022/1997-3187-2024-18-2-194-201
Reference Type
RESULT
Belenkov YN, Lishuta AS, Slepova OA, Nikolaeva NS, Khabarova NV, Dadashova GM, Privalova EV. The EXCEL Study: Long-term Observation of the Effectiveness of Drug and Non-drug Rehabilitation in Patients with Ischemic Heart Failure. Kardiologiia. 2024 Jan 31;64(1):14-24. doi: 10.18087/cardio.2024.1.n2615. English, Russian.
Reference Type
RESULT
Lishuta A.S., Slepova O.A., Nikolaeva N.A., Khabarova N.V., Privalova E.V., Belenkov Yu.N. Effectiveness of different treatment regimens of enhanced external counterpulsation in patients with stable coronary artery disease complicated by heart failure. Rational Pharmacotherapy in Cardiology. 2024;20(1):35-45. https://doi.org/10.20996/1819-6446-2024-3004.
Reference Type
RESULT
Lishuta A.S., Slepova O.A., Nikolaeva N.A., Petruhnova M.F., Privalova E.V., Belenkov Yu.N. Long-term effects of enhanced external counterpulsation in the management of patients with ischemic chronic heart failure. Rational Pharmacotherapy in Cardiology. 2024;20(2):194-201. https://doi.org/10.20996/1819-6446-2024-3041
Reference Type
RESULT
Lishuta A.S., Slepova O.A., Nikolaeva N.S., Privalova E.V., Belenkov Yu.N. Long-term effects of enhanced external counterpulsation in the management of patients with coronary artery disease complicated by heart failure: data from the EXCEL study. Russian Journal of Cardiology. 2024;29(6):5886. https://doi.org/10.15829/1560-4071-20245886.
Reference Type
RESULT
Lishuta A.S., Privalova E.V., Belenkov Yu.N. Enhanced external counterpulsation in the management of patients with ischemic heart failure: long-term impact on clinical outcomes. Cardiovascular Therapy and Prevention. 024;23(8):4015. https://doi.org/10.15829/1728-88002024-4015
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SUCT10122020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Hospital-Community-Family-Care Management Platform for Chronic Heart Failure
NCT02029287
UNKNOWN
NA
ContriBution of Digital RemOte MoniToring to IMPROVing The Effectiveness of Treatment in Patients With Chronic Heart Failure With Low Ejection Fraction
NCT06304753
RECRUITING
NA
Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of HFpEF
NCT02638961
COMPLETED
NA
Interval Training in Heart Failure
NCT03955029
RECRUITING
NA
Frailty Score Assessment for Elderly Patients Undergoing Cardiac Resynchronization Therapy
NCT02369419
COMPLETED
Accelerated Pacing and Cardiac Filling Pressures During Exercise in Patients With Heart Failure With Preserved Ejection Fraction
NCT07270536
RECRUITING
NA
CHF Management Using Telemedicine
NCT00309764
COMPLETED
NA
Effects of Remote Monitoring of Patients With Heart Failure Based on Smartphone Application
NCT04591964
UNKNOWN
EARLY_PHASE1
Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS
NCT04739098
ACTIVE_NOT_RECRUITING
HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study
NCT03991871
UNKNOWN
NA
Peripheral Venous Oxygen Saturation and Biomarkers to Estimate Cardiac Output and Filling Pressures in Heart Failure
NCT00595738
COMPLETED
Predictors and Outcomes of In-hospital HFpEF in AMI Patients
NCT03351179
UNKNOWN
Spinal Cord Stimulation in Hypotensive Heart Failure Patients: Hemodynamic Assessment
NCT05288387
TERMINATED
NA
ReGistry of hypeRtrophic cArDIomyopathy: Regional fEatures, geNeTics and Course
NCT07295613
ENROLLING_BY_INVITATION
Molecular Pathways of Cardiac Remodellation in Patients With Acute and Chronic Left Ventricular Disfunction
NCT05745571
UNKNOWN
NA
Whole Heart Radiotherapy for End-stage Heart Failure
NCT06299176
ENROLLING_BY_INVITATION
PHASE1
Telemedical Interventional Monitoring in Heart Failure
NCT00543881
COMPLETED
PHASE3
Improving Care of Patients With Heart Failure
NCT01461681
COMPLETED
NA
Non-invasive Ventilation in Patients With Cardiac Heart Failure
NCT05433610
COMPLETED
NA
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
NCT07008729
ACTIVE_NOT_RECRUITING
NA
High-intensity Interval Training in Heart Failure Patients With Preserved Ejection Fraction
NCT03184311
UNKNOWN
NA
A Clinical Follow-up Study of Heart Failure Patients.
NCT03797742
UNKNOWN
Characterization of Heart Failure With Preserved Ejection Fraction
NCT03197350
RECRUITING
NA
New Model of Care in Heart Failure
NCT03476590
COMPLETED
NA