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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)
Conditions: Atrial Fibrillation, Heart Failure
Sex: All
Ages: 65 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 1356
Sponsor: Jiangsu Taizhou People's Hospital
Location: Village Clinics in Dongtai City, Jiangsu Province Yancheng Dongtai
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.
Eligibility Criteria
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 \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 \
Source: ClinicalTrials.gov (NCT07492498). StuddyBuddy aggregates publicly available trial information.