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NCT Number: NCT07492524

Novel Model of Integrated Care of Older Patients With Atrial Fibrillation and Heart Failure in Rural China (MIRACLE-AFHF)

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Village Clinics in Dongtai City, Jiangsu Province, Yancheng, Dongtai, China

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

  • Expected life expectancy of less than 12 months.
  • Severe renal insufficiency (Ccr < 30ml/min) or ongoing dialysis treatment.
  • Cardiac insufficiency secondary to correctable causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
  • Indications for pacemaker implantation without having undergone implantation.
  • Chronic obstructive pulmonary disease (COPD) complicated by type II respiratory failure.
  • Special populations, including patients with mental illnesses.

Treatment and study plan

Village-Doctor Led Integrated Care

Other
  • Village doctors will conduct monthly follow-up, including clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed.
  • For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations.
  • Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles.
  • Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.

Usual Care

Other

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.

Primary outcomes

  1. Change in MAGGIC Heart Failure Risk Score

    Time frame: 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.

  2. Composite Cardiovascular Endpoint

    Time frame: 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 outcomes

  1. Cardiovascular Death

    Time frame: 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

  2. Cardiovascular Hospitalization

    Time frame: 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.

  3. Emergency Visit for Cardiovascular Events

    Time frame: 12 months after baseline

    Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.

  4. ischemic or hemorrhagic Stroke

    Time frame: 12 months after baseline

    All strokes: ischemic or hemorrhagic Stroke

  5. The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care

    Time frame: 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'

  6. GDMT medication utilization rate

    Time frame: 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%.

  7. Cardiovascular Death

    Time frame: 36 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 deathTime

  8. Ischemic or hemorrhagic Stroke

    Time frame: 36 months after baseline

    All strokes: ischemic or hemorrhagic Stroke

  9. Worsening of heart failure or acute coronary syndrome

    Time frame: 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

  10. Emergency visit due to AF

    Time frame: 36 months after baseline

    Emergency visit due to AF

  11. All-cause mortality

    Time frame: 36 months after baseline

    all-cause death

  12. The proportion of patients who met all the three criteria for the ABC pathway

    Time frame: 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'

  13. GDMT medication utilization rate

    Time frame: 36 months after baseline

    The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 36 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%.

  14. Change in MAGGIC Heart Failure Risk Score

    Time frame: 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.

  15. GDMT Score

    Time frame: 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.

  16. GDMT Score

    Time frame: Baseline to 36 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ming Chu

CONTACT

[email protected]

13814010410

Sponsors and collaborators

Lead sponsor

Jiangsu Taizhou People's Hospital

Other

Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Registry information

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 25, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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