Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation (EECP AF CR)

Lanzhou University Second Hospital

Status: Not yet enrolling

Conditions: Heart Failure (HF); Cardiac Rehabilitation; Atrial Fibrillation (AF)

Treatments: Behavioral: Cardiac Rehabilitation Combined With EECP; Other: Routine Medical Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07058987

lanzhou university (Other Identifier)

LZUSH-AFCR-2025-001

Details and patient eligibility

About

This is a prospective randomized controlled trial designed to evaluate the effectiveness of enhanced external counterpulsation (EECP) combined with cardiac rehabilitation in patients with atrial fibrillation. The study aims to assess whether this combined intervention can improve cardiac function and exercise capacity compared to standard care alone. Eligible participants will be randomly assigned to receive either the EECP plus cardiac rehabilitation program or routine treatment. Primary outcomes include changes in left ventricular ejection fraction (LVEF) and six-minute walking distance (6MWD). The study will be conducted at Lanzhou University Second Hospital.

Full description

Atrial fibrillation (AF) is a common cardiac arrhythmia associated with impaired ventricular function, reduced exercise tolerance, and increased risk of cardiovascular events. While pharmacological treatments and catheter ablation are widely used, non-pharmacological interventions such as enhanced external counterpulsation (EECP) and cardiac rehabilitation (CR) may offer additional benefits for improving cardiac performance and quality of life. This prospective, single-center, randomized controlled trial aims to evaluate the effects of EECP combined with a structured cardiac rehabilitation program in patients with persistent or paroxysmal atrial fibrillation. A total of approximately 200 eligible participants will be randomized in a 1:1 ratio to receive either EECP plus cardiac rehabilitation (intervention group) or routine medical care (control group) for a defined treatment period. The cardiac rehabilitation program will include individualized exercise training, health education, risk factor management, and follow-up support. EECP will be performed according to standard protocols for cardiovascular patients. Primary outcome measures will include changes in left ventricular ejection fraction (LVEF) and six-minute walking distance (6MWD) from baseline to the end of the intervention. Secondary outcomes may include assessments of quality of life, symptoms, and biomarkers. Safety and feasibility will also be recorded. This study is expected to provide clinical evidence supporting the integration of EECP and cardiac rehabilitation as a non-invasive, multidimensional treatment approach in patients with atrial fibrillation.

Enrollment: 200 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 40 and 80 years
• Diagnosed with persistent or paroxysmal atrial fibrillation, confirmed by ECG or Holter
• Stable medical condition and able to participate in cardiac rehabilitation and EECP therapy
• Provided written informed consent

Exclusion criteria

• Recent acute myocardial infarction, unstable angina, or decompensated heart failure within the past 4 weeks
• Severe valvular heart disease or left ventricular ejection fraction <30%
• Severe peripheral vascular disease or deep vein thrombosis
• Severe pulmonary disease or active infection
• History of bleeding disorders or contraindications to EECP
• Cognitive impairment or psychiatric condition affecting study participation
• Participation in another clinical trial within the past 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

EECP + Cardiac Rehabilitation

Experimental group

Description:

Participants will receive enhanced external counterpulsation (EECP) plus a structured cardiac rehabilitation program that includes individualized aerobic exercise training, health education, psychological support and lifestyle counselling.

Treatment:

Behavioral: Cardiac Rehabilitation Combined With EECP

Routine Medical Care

Active Comparator group

Description:

Participants will continue to receive standard pharmacologic management and routine clinical follow-up for atrial fibrillation without EECP or formal cardiac rehabilitation.

Treatment:

Other: Routine Medical Care