No phaseRecruitingAge-related condition
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 (Academic or other)
- Enrolment
- 942 planned
- Conditions
- Atrial Fibrillation; Heart Failure
- Interventions
- Village-Doctor Led Integrated Care; Usual Care
- Ages
- older adults
- Registry
- NCT07492524
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Primary Outcome of Phase 1: Change in MAGGIC Heart Failure Risk Score
- Primary Outcome of Phase 2: Composite Cardiovascular Endpoint
- Primary Outcome of Extension Study: Composite cardiovascular endpoint
History
Primary completion expected
Last registry update
Started
Registered