NCT07492498Recruiting
A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1356 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 26 Jul 2026
- Primary completion date
- 30 Dec 2033
- Lead sponsor
- Jiangsu Taizhou People's Hospital
- Diseases
- Heart failure, Atrial fibrillation
- NCT number
- NCT07492498
What you commit to
- Study type: Interventional
- Planned participants: 1356
- From 26 Jul 2026 to the primary completion date, 30 Dec 2033
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cardiac dysfunction caused by reversible secondary causes, including hyperthyroid heart disease, anemic heart disease, or uncorrected congenital heart disease.
- Chronic obstructive pulmonary disease complicated by type II respiratory failure.
- Special populations, such as patients with mental illness.
Lab values
- 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.
- Severe renal insufficiency, defined as creatinine clearance \<30 mL/min, or currently receiving dialysis treatment.
Other
- Expected survival of less than 12 months.
- Indication for pacemaker implantation but without pacemaker placement.
Who the study is looking for
- 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.
Age in the registry: 65 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Village Clinics in Suining County, Jiangsu Province Coordinator of this site? Confirm its status | Xuzhou | China | Recruiting |
| Village Clinics in Dongtai City, Jiangsu Province Coordinator of this site? Confirm its status | Yancheng | China | Recruiting |
| Village Clinics in Jiangdu District, Jiangsu Province Coordinator of this site? Confirm its status | Yangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.