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NCT07492498

A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)

Sponsor: Jiangsu Taizhou People's Hospital

View on ClinicalTrials.gov

Summary

This cluster randomized study aims to compare village doctor-led integrated care versus usual care to improve cardiovascular health, atrial fibrillation management, self-management adherence, and heart failure prevention among older rural patients with atrial fibrillation in China.The primary outcome at 12 months is the change in Life's Essential 8 cardiovascular health score from baseline (phase 1). The primary outcome at 36 months is a composite cardiovascular endpoint including cardiovascular death, ischemic or hemorrhagic stroke, hospitalization for worsening HF or acute coronary syndrome, and emergency department visits due to AF (phase 2) . The primary outcome at 48 months is new-incident heart-failure diagnosis (phase 3) .An extended observational follow-up, the new-incident heart-failure diagnosis observational follow-up study, will be conducted at Year 7 to evaluate long-term effects.

Key Details

Gender

All

Age Range

65 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1356

Start Date

2026-07-26

Completion Date

2033-12-30

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 contact per month will be completed at the clinic or at home, including symptom assessment, vital-sign monitoring, medication adherence management, cardiovascular risk-factor control and health guidance. 2. Telemedicine specialist support. When symptoms fluctuate, treatment adjustment is difficult or a management problem arises, the village doctor may upload symptoms, ECG recordings, medication information and examination materials through a dedicated telemedicine platform. 3. Standardised guideline training. Village doctors will receive training centred on the AF ABC pathway, covering stroke prevention and anticoagulation, better symptom control, cardiovascular risk-factor management, referral criteria and endpoint identification. 4. Simplified exercise rehabilitation and lifestyle education. Village doctors will deliver enhanced health education in accordance with the study team's 15 core messages for lifestyle-related management

OTHER

Usual Care

Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. 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)Availability of an electrocardiogram confirming atrial fibrillation, or an official diagnosis certificate of atrial fibrillation issued by a specialist. 3)Receiving healthcare management from a primary medical institution near the place of residence. 4)Able to understand and sign the informed consent form. Exclusion Criteria: 1. 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. 2. Expected survival of less than 12 months. 3. Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment. 4. Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease. 5. Indication for pacemaker implantation but without pacemaker placement. 6. Chronic obstructive pulmonary disease complicated by type II respiratory failure. 7. Special populations, such as patients with mental illness.

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