No phaseRecruitingAge-related condition

A Village Doctor-led Telehealth Supported Trial of Heart Failure Prevention in AF Patients: MIRACLE-AF 2 (Heart Failure Prevention)

Sponsor
Jiangsu Taizhou People's Hospital (Academic or other)
Enrolment
1,356 planned
Conditions
Atrial Fibrillation; Heart Failure
Interventions
Village-Doctor Led Integrated Care; Usual Care
Ages
older adults
Registry
NCT07492498

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Primary Outcome of Phase 1: Change in Life's Essential 8 Cardiovascular Health Score
  • Primary Outcome of Phase 2: Composite Cardiovascular Outcome
  • Primary Outcome of Phase 3: New-incident heart-failure diagnosis
  • Primary Outcome of Extension Study: Composite cardiovascular outcome

History

  1. Primary completion expected

  2. Last registry update

  3. Started

  4. Registered