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RECRUITING

NCT07492524

A Village Doctor-led Telehealth Supported Improvement of Outcomes of AF Patients With Heart Failure Due to Reduced or Preserved Ejection Fraction: The MIRACLE-AF 2 Heart Failure Management Trial (MIRACLE AF-HF)

Sponsor: Jiangsu Taizhou People's Hospital

View on ClinicalTrials.gov

Summary

The primary objective is to determine whether a telemedicine-supported, village doctor-led integrated management model, AF-HF comorbidity ABC pathway and enhanced patient education, improves clinical outcomes compared with usual care among rural residents aged 65-80 years with AF and HF. The trial will evaluate whether integrated management reduces the MAGGIC HF risk score at 12 months (phase 1) and whether it reduces a 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 over 36 months (phase 2). An extended observational follow-up, the composite cardiovascular endpoint observational follow-up study, will be conducted at Year 6 to evaluate long-term effects.

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

942

Start Date

2026-07-26

Completion Date

2032-12-30

Last Updated

2026-10-07

Healthy Volunteers

Conditions

Atrial Fibrillation Heart Failure

Interventions

OTHER

Village-Doctor Led Integrated Care

1. Village doctor-led management: At least one follow-up visit per month will be conducted either at the village clinic or in the patient's home, including assessment of clinical status, monitoring of vital signs, medication review, risk screening, and health education. 2. Telemedicine specialist support: When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, blood pressure, heart rate and examination materials through a dedicated telemedicine platform. 3. Standardised guideline training. Village doctors will receive tiered training based on the AF-HF comorbidity ABC pathway. 4. Patient education: Participants will receive the study team's 18 core AF-HF self-management messages through monthly face-to-face education, regular short-message reminders and illustrated brochures, reinforcing medication adherence, symptom monitoring, salt and fluid restriction, exercise rehabilitation.

OTHER

Usual 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.

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 newly diagnosed HF according to the 2026 ESC Guidelines for the management of heart failure. HF will require current or prior typical symptoms and/or signs attributable to a structural and/or functional cardiac abnormality. Participants with LVEF \<50% will be classified as having heart failure with reduced ejection fraction (HFrEF). In participants with LVEF ≥50%, heart failure with preserved ejection fraction (HFpEF) will require objective evidence of cardiac structural and/or functional abnormalities consistent with left ventricular diastolic dysfunction or elevated filling pressures, supported by elevated natriuretic peptide levels. In participants with AF, supportive echocardiographic abnormalities will include left atrial volume index (LAVI) \>40 mL/m², E/e' \>15, pulmonary artery systolic pressure \>35 mmHg, or tricuspid regurgitation velocity \>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.

Locations (3)

Village Clinics in Dongtai City, Jiangsu Province

Yancheng, Dongtai, China

Village Clinics in Jiangdu District, Jiangsu Province

Yangzhou, Jiangdu, China

Village Clinics in Suining County, Jiangsu Province

Xuzhou, Suining, China