Atrial Fibrillation (AF)EECP AF CRNCT07058987
Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation in Patients With Atrial Fibrillation
A study testing Cardiac Rehabilitation Combined With EECP and Routine Medical Care in people with Atrial Fibrillation (AF) and Heart Failure (HF), run by Lanzhou University Second Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF), Heart Failure (HF), Cardiac Rehabilitation
- What is being tested?
- Cardiac Rehabilitation Combined With EECP and Routine Medical Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Xiaowei Zhang, 17701272944, yanxiwenny@foxmail.com
About this study
Official title: A Prospective Randomized Controlled Study on the Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation on Cardiac Function and Exercise Capacity in Patients With Atrial Fibrillation
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.
Read the 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.
- Being tested
- Cardiac Rehabilitation Combined With EECP, Routine Medical Care
- Keywords
- Atrial Fibrillation, Cardiac Rehabilitation, Enhanced External Counterpulsation, Exercise Capacity
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Rehabilitation Combined With EECPBehavioural
Also called Enhanced External Counterpulsation, EECP, Cardiac Rehabilitation, CR
This intervention consists of a comprehensive cardiac rehabilitation program that includes individualized aerobic exercise training, health education, psychological support, and lifestyle counseling, combined with enhanced external counterpulsation (EECP) therapy administered according to standard cardiovascular protocols. The combined intervention is designed to improve cardiac function, exercise tolerance, and quality of life in patients with atrial fibrillation.
Routine Medical CareOther
Also called Standard Care, Usual Care, Pharmacological Management
Participants in the control group will receive standard medical treatment for atrial fibrillation as prescribed by their attending physicians, without enhanced external counterpulsation or structured cardiac rehabilitation. This may include pharmacological therapy, routine clinical monitoring, and general lifestyle advice.
| Study group | Role | What they receive |
|---|---|---|
| EECP + Cardiac Rehabilitation | Experimental | 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. Receives: Behavioral: Cardiac Rehabilitation Combined With EECP |
| Routine Medical Care | Active comparator | Participants will continue to receive standard pharmacologic management and routine clinical follow-up for atrial fibrillation without EECP or formal cardiac rehabilitation. Receives: Other: Routine Medical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12
LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.
Measured: Baseline and 12 weeks after intervention
Secondary outcomes (4)
Change in 6-Minute Walk Distance (6MWD)
6MWD will be measured to assess changes in functional exercise capacity.
Measured: Baseline and 12 weeks
Incidence of Adverse Events
All adverse events related to EECP or cardiac rehabilitation will be recorded to assess safety and tolerability.
Measured: Throughout the 12-week intervention period
Change in NT-proBNP Level
Blood samples will be collected to assess changes in NT-proBNP, a biomarker of cardiac stress and heart failure severity.
Measured: Baseline and 12 weeks
Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score
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.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jul 2025 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group (receiving EECP combined with cardiac rehabilitation) or the control group (receiving routine medical care). Each participant will remain in their assigned group throughout the study.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lanzhou University Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaowei Zhang, Lanzhou University Second Hospital
- Investigators
- Xiaowei Zhang PhD, Principal investigator, Lanzhou University Second Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058987
- Sponsor's protocol ID
- LZUSH-AFCR-2025-001
- Other IDs
- lanzhou university
- Acronym
- EECP AF CR
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study on the Effects of Enhanced External Counterpulsation Combined With Cardiac Rehabilitation on Cardiac Function and Exercise Capacity in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT07058987
- Acronym / sponsor ID
- EECP AF CR / LZUSH-AFCR-2025-001
- Keywords
- Atrial Fibrillation, Cardiac Rehabilitation, Enhanced External Counterpulsation, Exercise Capacity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lanzhou University Second HospitalUniversity, hospital or other
- Study start
- 15 Jul 2025 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the intervention group (receiving EECP combined with cardiac rehabilitation) or the control group (receiving routine medical care). Each participant will remain in their assigned group throughout the study.
| Arm | Type | Receives |
|---|---|---|
| EECP + Cardiac Rehabilitation | Experimental | Behavioral: Cardiac Rehabilitation Combined With EECPParticipants 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. |
| Routine Medical Care | Active comparator | Other: Routine Medical CareParticipants will continue to receive standard pharmacologic management and routine clinical follow-up for atrial fibrillation without EECP or formal cardiac rehabilitation. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Rehabilitation Combined With EECPAlso: Enhanced External Counterpulsation, EECP, Cardiac Rehabilitation, CRThis intervention consists of a comprehensive cardiac rehabilitation program that includes individualized aerobic exercise training, health education, psychological support, and lifestyle counseling, combined with enhanced external counterpulsation (EECP) therapy administered according to standard cardiovascular protocols. The combined intervention is designed to improve cardiac function, exercise tolerance, and quality of life in patients with atrial fibrillation. | Behavioural | EECP + Cardiac Rehabilitation |
| Routine Medical CareAlso: Standard Care, Usual Care, Pharmacological ManagementParticipants in the control group will receive standard medical treatment for atrial fibrillation as prescribed by their attending physicians, without enhanced external counterpulsation or structured cardiac rehabilitation. This may include pharmacological therapy, routine clinical monitoring, and general lifestyle advice. | Other | Routine Medical Care |
Primary outcome
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12
Time frame: Baseline and 12 weeks after intervention
LVEF will be assessed using transthoracic echocardiography to evaluate improvement in systolic cardiac function.
4 secondary outcomes
Change in 6-Minute Walk Distance (6MWD)
Time frame: Baseline and 12 weeks
Incidence of Adverse Events
Time frame: Throughout the 12-week intervention period
Change in NT-proBNP Level
Time frame: Baseline and 12 weeks
Change in Health-Related Quality of Life (HRQoL) Measured by SF-36 Total Score
Time frame: Baseline and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
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Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaowei Zhang PhD principal investigator
Lanzhou University Second Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Rehabilitation Combined With EECP and Routine Medical Care in people with Atrial Fibrillation (AF) and Heart Failure (HF), run by Lanzhou University Second Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowei Zhang PhD (17701272944, yanxiwenny@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Left Ventricular Ejection Fraction (LVEF) from Baseline to Week 12 (time frame: Baseline and 12 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.