Long-tErm Effects of Enhanced eXternal CountErpuLsation

NCT05913778 | Completed

• 1 other identifier: SUCT10122020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Artery Disease; Chronic Heart Failure

Keywords

coronary artery disease; chronic heart failure; enhanced external counterpulsation; structural and functional vascular state; clinical status; exercise tolerance; quality of life; cardiovascular events

Outcome Measures

Primary Outcomes (1)

• Composite primary endpoint

  combination of vascular event (myocardial infarction, acute cerebrovascular accident, revascularization procedures), hospitalization (for CAD/CHF), death

  12 months, 24 months, 36 months

Secondary Outcomes (3)

• Exercise tolerance

  3 months, 6 months, 12 months, 24 months, 36 months

• Antianginal therapy

  12 months, 24 months, 36 months

• Angina episodes

  12 months, 24 months, 36 months

Study Arms (3)

Enhanced external counterpulsation 35 hours per year

EXPERIMENTAL

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

Device: Enhanced external counterpulsation

Enhanced external counterpulsation 70 hours per year

EXPERIMENTAL

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

Device: Enhanced external counterpulsation

SHAM external counterpulsation

SHAM COMPARATOR

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

Device: Enhanced external counterpulsation

Interventions

Enhanced external counterpulsation 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.

Also known as: EECP

Enhanced external counterpulsation 35 hours per year; Enhanced external counterpulsation 70 hours per year; SHAM external counterpulsation

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

I.M. Sechenov First Moscow State Medical University (Sechenov University)

Moscow, 119991, Russia

Location

Related Publications (13)

• 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

  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

  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

  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

  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

  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

  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

  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

  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.

  PMID: 38323440 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.

  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

  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.

  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

  RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Alexey Lishuta, MD, PhD

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: open, prospective, randomized, controlled in parallel groups

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 22, 2023
• Study Start: December 10, 2020
• Primary Completion: December 10, 2021
• Study Completion: January 15, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-10

Locations

RU (1)