Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07058987
• Lead Sponsor: Lanzhou University Second Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-14
• Study Start: 2025-07-15
• Primary Completion: 2026-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12	Baseline and 12 weeks after intervention	LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.

Secondary Outcome Measures

Name	Time	Method
Change in 6-Minute Walk Distance (6MWD)	Baseline and 12 weeks	6MWD will be measured to assess changes in functional exercise capacity.
Incidence of Adverse Events	Throughout the 12-week intervention period	All adverse events related to EECP or cardiac rehabilitation will be recorded to assess safety and tolerability.
Change in NT-proBNP Level	Baseline and 12 weeks	Blood samples will be collected to assess changes in NT-proBNP, a biomarker of cardiac stress and heart failure severity.
Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score	Baseline and 12 weeks	The validated Chinese version of the Short-Form 36 Health Survey (SF-36; total score range 0 - 100, with higher scores indicating better health status) will be administered face-to-face by trained study nurses at baseline and Week 12. The primary metric will be the change in total SF-36 score computed using the standard scoring algorithm.

Trial Locations

Locations (1)

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China