Atrial Fibrillation, Heart Failure
Conditions
Brief summary
This cluster randomization study aims to compare village-doctor led integrated care versus usual care to improve heart failure risk management, guideline-directed medical therapy, self-management adherence, and clinical outcomes for older patients with atrial fibrillation and heart failure in rural China.
Detailed description
BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and interact bidirectionally, creating a vicious cycle that increases the risks of hospitalization, stroke, cardiovascular death, and all-cause mortality in older adults. Although adherence to the Atrial Fibrillation Better Care (ABC) pathway has been shown to improve AF management, older patients with coexisting AF and HF in rural China remain particularly vulnerable because of inadequate HF screening and risk stratification, suboptimal implementation of guideline-directed medical therapy (GDMT), and insufficient long-term follow-up. China's rural healthcare system relies heavily on village doctors for the delivery of primary care. However, village doctors often have limited access to clinical resources, standardized training, and specialist support, which may hinder the optimal management of patients with AF-HF comorbidity. A village-doctor-led integrated care model incorporating regular follow-up, medication review, clinical risk monitoring, guideline-based treatment, timely specialist consultation, and structured patient education may therefore improve disease management and clinical outcomes in this high-risk population. AIM OF THE STUDY This cluster-randomized trial aims to evaluate whether village-doctor-led integrated care, compared with usual care, improves HF risk management, adherence to guideline-recommended treatment, and clinical outcomes among older adults with coexisting AF and HF in rural China. STUDY DESIGN This is a prospective, cluster-randomized, open-label, parallel-group clinical trial conducted in rural areas of Jiangsu Province, China. The study plans to enroll rural residents aged 65-80 years with documented AF and either previously diagnosed or screening-detected HF from approximately 50 village clinics. Village clinics will be randomized in a 1:1 ratio to either the intervention group or the control group. Participants in the intervention group will receive village-doctor-led integrated care, including monthly follow-up; monitoring of symptoms, vital signs, and clinical risk factors; medication review; standardized risk assessment; guideline-based management according to the AF ABC pathway and HF GDMT recommendations; specialist consultation when clinically indicated; and structured education on self-management. Participants in the control group will receive usual chronic disease management in accordance with the requirements of China's National Basic Public Health Service Program. All participants will be followed for up to 36 months
Interventions
1. Village doctors will conduct monthly follow-up, including clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed. 2. For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations. 3. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. 4. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
OTHERUsual Care
Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Sponsors
Jiangsu Taizhou People's Hospital
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1\. The village clinics need to be willing and able to provide integrated care to their patients with atrial fibrillation; 2. The village doctors from one village clinic serves all AF patients from 3-5 nearby villages; 3. The village doctors are trained to have a fundamental understanding of telemedicine; 4. Patients are eligible for participation if 1)they aged 65-80 years. 2) Electrocardiogram (ECG) confirmation of AF or possession of a diagnostic certificate for AF issued by a specialist. 3) A documented history of HF or a diagnosis of HF based on echocardiography and/or NT-proBNP screening, defined by the presence of typical HF symptoms and/or signs, together with one of the following: reduced left ventricular ejection fraction (HFrEF; LVEF \< 40%), mildly reduced left ventricular ejection fraction (HFmrEF; LVEF 40-49%), or preserved left ventricular ejection fraction with elevated NT-proBNP and structural heart disease changes (HFpEF; LVEF ≥ 50%, meeting at least one of the following criteria: LAV 40 ml/m², E/e' ≥ 15, or TRV \> 2.8 m/s). 4) Management by a village clinic near the participant's place of residence. 5) Ability to understand the study procedures and provide written informed consent.
Exclusion criteria
1. Expected life expectancy of less than 12 months. 2. Severe renal insufficiency (Ccr \< 30ml/min) or ongoing dialysis treatment. 3. Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease. 4. Indications for pacemaker implantation without having undergone implantation. 5. Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure. 6. Special populations, including patients with mental illnesses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MAGGIC Heart Failure Risk Score | Baseline to 12 months | A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status. |
| Composite Cardiovascular Endpoint | 36 months after baseline | Composite cardiovascular endpoint, including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening heart failure or acute coronary syndrome, and emergency visits due to atrial fibrillation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular Death | 12 months after baseline | Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death |
| Cardiovascular Hospitalization | 12 months after baseline | Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack. |
| Emergency Visit for Cardiovascular Events | 12 months after baseline | Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome. |
| ischemic or hemorrhagic Stroke | 12 months after baseline | All strokes: ischemic or hemorrhagic Stroke |
| The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care | 12 month after baseline | The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) \>65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant' |
| GDMT medication utilization rate | 12months after baseline | The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 12 Months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%. |
| Ischemic or hemorrhagic Stroke | 36 months after baseline | All strokes: ischemic or hemorrhagic Stroke |
| Worsening of heart failure or acute coronary syndrome | 36 months after baseline | A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions |
| Emergency visit due to AF | 36 months after baseline | Emergency visit due to AF |
| All-cause mortality | 36 months after baseline | all-cause death |
| The proportion of patients who met all the three criteria for the ABC pathway | 36 month after baseline | The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) \>65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant' |
| Change in MAGGIC Heart Failure Risk Score | Baseline to 36 months | Description: A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status. |
| GDMT Score | Baseline to 12 months | β-blockers are scored as 0, 1, or 2 points for no use, use at \<50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at \<50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines. |
Countries
China
Contacts
CONTACTMing Chu
Outcome results
None listed