2026-07-25
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measures v2
Secondary endpointsdetails revised at 1 of 16 entries
Study description+291 characters
BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and interact with each otherbidirectionally, formingcreating a vicious cycle that increases the risks of hospitalization [...] oke, cardiovascular death, and all-cause mortality in older patientsadults.
Although adherence to the Atrial Fibrillation Better Care (ABC) pathway helpshas been shown to improve AF management, older patients with coexisting AF and HF in rural China remain particularly vulnerable because of insufficientinadequate HF screening, and risk stratification, suboptimal implementation of guideline-directed [...] [...]
Collaborators+61 characters
The First Affiliated Hospital with Nanjing Medical University
2026-07-13
critical
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing, References v1
Recruitment opened
Primary endpoint(s) modified2 entries, revised
WasChange in Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) Risk Score, Number of Participants Experiencing a Composite Cardiovascular Endpoint
NowChange in MAGGIC Heart Failure Risk Score, Composite Cardiovascular Endpoint
Enrollment reduced: 1227 → 942 participants
Trial sites expanded: 0 → 3 locations
Primary completion pushed: 2029-04-01 → 2029-12-30
Completion pushed: 2029-04-01 → 2029-12-30
Start date2026-03-25→2026-08-01
InterventionsConventional Management (Other), Digital Intelligent Integrated Management (Behavioral)→Usual Care (Other), Village-Doctor Led Integrated Care (Other)
Eligibility criteria+256 characters
Inclusion1.
The Criteria:
Permanentvillage residentsclinics need to be willing and able to provide integrated care to their patients with localatrial householdfibrillation; registration2. atThe thevillage primarydoctors levelfrom inone Jiangsuvillage Province,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 d [...] [...]
Secondary endpoints9 to 16 entries
Number of Participants with Cardiovascular Death at 12 Months
Number of Participants with Cardiovascular-Related Hospitalization at 12 Months
Number of Participants with Emergency VisitsVisit for Cardiovascular Events
ischemic ator 12hemorrhagic MonthsStroke
NumberThe proportion of Participantspatients withwho Strokemet atall 12the Months
Numberthree criteria for the ABC pathway of Participantsintegrated withAF care
GDMT medication utilization rate
Cardiovascular Death
Ischemic ator 36hemorrhagic MonthsStroke
NumberWorsening of Participantsheart withfailure Cardiovascularor acute coronary synd [...] [...]
Study description+299 characters
BACKGROUND Atrial fibrillation (AF) and heart failure (HF) frequently coexist and mutuallyinteract reinforcewith oneeach anotherother, forming a "vicious cycle" that isincreases particularlythe destructiverisks of hospitalization, stroke, cardiovascular death, and all-cause mortality in older adultspatients.
OlderAlthough the Atrial Fibrillation Better Care (ABC) pathway helps improve AF management, older patients with AF are at high risk forand HF progression, and AF-HF comorbidity is a central determinant of long-term prognosis.
Inin rural China, effectiveremain preventionvulnerable andbecau [...] [...]
Study title+3 characters
Telemedicine-basedNovel Model of Integrated ManagementCare of Older Patients With Atrial Fibrillation and Heart Failure in OlderRural PatientsChina in Village Clinics(MIRACLE-AFHF)