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

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered