Atrial fibrillation heart failure
Conditions
Interventions
Trial Group:Ear acupressure with magnetic beads (acupoints: Heart, Sympathetic, Shenmen, Occiput, Kidney, Cortex Supra) using stone patches, pressed 3 times daily for 1 minute each time, plus standard
Control Group:Non-acupoint ear patching and pressing (patches applied to non-therapeutic areas of the ear, visually identical to the trial group) plus standardized drug therapy (beta-blockers or calci
Sponsors
The First Affiliated Hospital of USTC,Division of Life Sciences and Medicine,University of Science and Technology of China
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Core Disease Diagnosis Heart Failure Diagnosis (all of the following must be met): (1) Meets the diagnostic criteria for chronic heart failure according to the 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure, and is clinically stable (defined as no acute exacerbation of heart failure within the past 4 weeks, requiring no adjustment of intravenous medications due to worsening heart failure); (2) New York Heart Association (NYHA) functional class II–III. Atrial Fibrillation Diagnosis (all of the following must be met): (1) Confirmed by electrocardiogram as persistent or paroxysmal atrial fibrillation (according to the 2020 ESC/EACTS Guidelines for the Diagnosis and Management of Atrial Fibrillation); (2) Baseline atrial fibrillation ventricular rate >= 100 beats per minute before enrollment (confirmed by electrocardiogram or Holter monitoring). 2. Demographic and Treatment Background (1) Age 40–85 years; (2) Receiving stable-dose pharmacotherapy for >= 4 weeks (including beta-blockers, diuretics, anticoagulants, ARNI/ACEI/ARB, MRA, SGLT2 inhibitors). 3. Special Requirements (1) Able to tolerate auricular plaster application/pressure stimulation; (2) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Disease-Related Exclusion Criteria (1) Acute decompensated heart failure; (2) Atrial fibrillation requiring emergency electrical cardioversion or catheter ablation; (3) Second-degree or higher atrioventricular block or sick sinus syndrome. 2. Intervention-Related Exclusion Criteria (1) Auricular deformity, infection, or skin disease (e.g., eczema, psoriasis); (2) Implanted cardiac pacemaker or implantable cardioverter-defibrillator (ICD) (to avoid electrical stimulation interference). 3. Confounding Factors (1) Participation in another clinical trial within the past 3 months; (2) Severe hepatic or renal insufficiency (eGFR < 30 mL/min/1.73 m^2 or Child-Pugh class C); (3) Expected survival < 6 months (e.g., advanced malignancy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean ventricular rate;European Heart Rhythm Association symptom score;NT-proBNP;6-minute walk test distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Atrial fibrillation burden;Kansas City Cardiomyopathy Questionnaire score ;Cardiovascular disease readmission rate; | — |
Countries
China
Contacts
Public ContactWang Zhe
The First Affiliated Hospital of USTC,Division of Life Sciences and Medicine,University of Science and Technology of China
Outcome results
None listed