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)
| NCT ID | NCT07492524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jiangsu Taizhou People's Hospital |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 942 participants |
| Start Date | 2026-07-26 |
| Primary Completion | 2032-12-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 942 participants in total. It began in 2026-07-26 with a primary completion date of 2032-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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) 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07492524 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 80 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07492524 currently recruiting?
Yes, NCT07492524 is actively recruiting participants. Contact the research team at chuming@njmu.edu.cn for enrollment information.
Where is the NCT07492524 trial being conducted?
This trial is being conducted at Yancheng, China, Yangzhou, China, Xuzhou, China.
Who is sponsoring the NCT07492524 clinical trial?
NCT07492524 is sponsored by Jiangsu Taizhou People's Hospital. The trial plans to enroll 942 participants.
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