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Novel Model of Integrated Care of Older Patients With Atrial Fibrillation to Prevent Heart Failure in Rural China

StatusRecruiting
PhaseNot applicable
Started2026-08-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Apr 1, 2030 → Jul 1, 2030
Primary endpoint reworded 3 of 3 changed
See other at-risk trials from Jiangsu Taizhou People's Hospital

Amendment history

2026-07-25
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measures v2
Study description+120 characters
BACKGROUND Atrial fibrillation (AF) is common inamong older adults and is strongly associated with heart failure [...] n, cardiovascular death, and all-cause mortality. AF and HF frequently interact with each otherbidirectionally and may form a viciousself-perpetuating cycle, especiallyparticularly in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway has beenis recommended to improve AFthe comprehensive management of AF, older patientsadults with AF in rural China remain particularly vulnerable because of limited access to specialist care, insufficientinadequate HF screening [...]
Collaborators+61 characters
The First Affiliated Hospital with Nanjing Medical University
2026-07-13
critical
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v1
Recruitment opened
Primary endpoint(s) modified3 entries, revised
WasMean Change from Baseline in the Overall Life's Essential 8 (LE8) Score, Number of Participants Experiencing a Composite Cardiovascular Endpoint Event, Number of Participants with Incident Asymptomatic Left Ventricular Dysfunction or Heart Failure
NowChange in Life's Essential 8 Cardiovascular Health Score, Composite Cardiovascular Outcome, Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure
Trial sites expanded: 0 → 3 locations
Primary completion pushed: 2030-04-01 → 2030-07-01
Completion pushed: 2030-04-01 → 2030-07-01
Start date2026-04-01→2026-08-01
Enrollment target1268→1356
InterventionsConventional Management Group (Other), Telemedicine-Based Integrated Care Model (Other)→Usual Care (Other), Village-Doctor Led Integrated Care (Other)
Eligibility criteria+281 characters
Inclusion Criteria: Permanent1. The residentsvillage clinics need to be willing and able to provide integrated care to their patients with householdatrial registrationfibrillation; in2. primaryThe carevillage jurisdictionsdoctors 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 Jiangsutelemedicine; Province,4. Patients are eligible for participation if 1)they aged 65 to -80 years;. 2)Availability of an electrocardiogram confirming atrial fibri [...] is certificate of atrial fibrillation issued by a speci [...]
Secondary endpoints9 to 17 entries
Number of Participants Experiencing Cardiovascular Death Number of Participants RequiringCardiovascular Hospitalization for Cardiovascular or Neurological Events Number of Participants with Emergency VisitsVisit for Cardiovascular Events Numberischemic or hemorrhagic Stroke The proportion of Participantspatients Experiencingwho amet all the three criteria for the ABC pathway of integrated AF care Cardiovascular Death Ischemic or hemorrhagic Stroke NumberWorsening of Participantsheart infailure Eachor Newacute Yorkcoronary Heartsyndrome Emergency Associationvisit (NYHA)due Functionalto ClassAF [...]
Study description+2,261 characters
BACKGROUND Atrial fibrillation (AF) is common in older adults and is strongly associated with heart failure (HF), frequentlystroke, coexisthospitalization, cardiovascular death, and preventingall-cause incidentmortality. AF and HF frequently interact with each other and may form a vicious cycle, especially in older patients. Although the Atrial Fibrillation Better Care (ABC) pathway has been recommended to improve AF management, older patients with AF in rural China remain vulnerable because of limited ac [...] HF in olderthis population. AIM OF THIS STUDY This cluster randomized study aims to compa [...] [...]
Study title-10 characters
Telemedicine-BasedNovel Model of Integrated Care for Heart Failure Prevention inof Older Patients With Atrial Fibrillation (MIRACLE-AFto III)Prevent Heart Failure in Rural China
2026-03-19
minor
Original filing
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.
Trial Details
NCT Number NCT07492498
Lead Sponsor Jiangsu Taizhou People's Hospital
Collaborators: The First Affiliated Hospital with Nanjing Medical University
Conditions Atrial Fibrillation, Heart Failure
Enrollment 1,356 participants
Start Date 2026-08-01
Primary Completion 2030-07-01 (estimated)
Study Completion 2030-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-28