Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Telemedicinsk integreret behandling til forebyggelse af hjertesvigt hos ældre patienter med atrieflimren (MIRACLE-AF III)

25. juli 2026 opdateret af: Jiangsu Taizhou People's Hospital

Forebyggelse af incident hjerteinsufficiens med en telemedicinsk integreret plejemodel blandt ældre patienter med atrieflimren i landdistrikterne i Kina: MIRACLE-AF-Prevention klynge-randomiseret forsøg

Formålet med denne undersøgelse er at forebygge hjertesvigt hos ældre voksne (i alderen 65-80 år), der bor i landlige områder af Kina og har atrieflimren, men som ikke i øjeblikket har hjertesvigt. Da atrieflimren øger risikoen for at udvikle hjertesvigt betydeligt, tester denne klynge-randomiserede undersøgelse, om en telemedicinsk-understøttet, landsbylæge-ledet integreret plejemodel kan forbedre den langsigtede kardiovaskulære sundhed sammenlignet med standardpleje. Deltagerne tildeles af deres lokale landsbyklinik til at modtage enten konventionel rutinemæssig medicinsk pleje eller et digitalt smart forvaltningsprogram. Det integrerede program omfatter brugen af bærbare enheder til at overvåge daglig sundhed, deltagelse i strukturerede livsstilsforbedringsprogrammer med fokus på motion, kost, rygestop og søvn samt modtagelse af optimerede medicinplaner understøttet af fjernkardiovaskulære specialister. Forskerne vil måle de samlede forbedringer i kardiovaskulær sundhed ved hjælp af Life's Essential 8-score efter 12 måneder, spore større kardiovaskulære hændelser som hjertesvigt-indlæggelser eller slagtilfælde efter 36 måneder og evaluere udviklingen af asymptomatisk hjertedysfunktion efter 48 måneder.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Atrieflimren (AF) og hjertesvigt (HF) forekommer ofte sammen, og forebyggelse af incident HF hos ældre AF-patienter er en kritisk klinisk udfordring, især i ressourcestærke landdistrikter. MIRACLE-AF III-forsøget er et klynge-randomiseret kontrolleret forsøg gennemført på tværs af 76 landsbyklinikker i Jiangsu-provinsen, Kina, med det formål at etablere en tidlig screenings- og upstream-risikokontrolmodel for ældre (65-80 år) med AF, men normal hjertefunktion ved baseline. Landsbyklinikker randomiseres i et 1:1-forhold til enten at tilbyde konventionel rutinemæssig medicinsk pleje eller et digitalt-smart integreret forvaltningsprogram. I interventionsarmen anvender landsbylæger en digital sundhedsplatform integreret med Internet of Things-medicinske enheder til at levere retningslinjedirigeret medicinsk terapi (GDMT) og ABC-sti-tilpasset pleje, støttet af fjern tele-konsultationer fra kardiovaskulære specialister, når kliniske mål ikke opnås. Desuden omfatter denne integrerede tilgang en struktureret multidimensionel livsstilsintervention, hvor deltagerne bruger bærbare enheder til kontinuerlig hjemmeovervågning af hjertefrekvens og søvn, deltager i månedlige peer-støtte kardiorehabiliteringssessioner i bygde sundhedscentre og modtager automatiseret, skræddersyet adfærdsmæssigt uddannelsesindhold vedrørende kost, rygningstop og søvnhygiejne.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1356

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
    • Dongtai
      • Yancheng, Dongtai, Kina, 224200
        • Rekruttering
        • Village Clinics in Dongtai City, Jiangsu Province
        • Kontakt:
    • Jiangdu
      • Yangzhou, Jiangdu, Kina, 225267
        • Rekruttering
        • Village Clinics in Jiangdu District, Jiangsu Province
        • Kontakt:
    • Suining
      • Xuzhou, Suining, Kina, 221200
        • Rekruttering
        • Village Clinics in Suining County, Jiangsu Province
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Fastboende med husholdningsregistrering i primære sundhedsplejedistrikter i Jiangsu-provinsen, i alderen 65 til 80 år;
  2. Tilgængelighed af et elektrokardiogram, der bekræfter atrieflimren, eller en officiel diagnosepåtegning for atrieflimren udstedt af en specialist;
  3. Modtager sundhedsplejestyring fra den primære medicinske institution tættest på bopælen;
  4. I stand til at forstå og underskrive informeret samtykkeerklæringen.

Eksklusionskriterier:

  1. En sikker historie med hjertesvigt, eller en bekræftet diagnose af hjertedysfunktion via ekkokardiografi og/eller NT-proBNP-screening. Diagnostiske kriterier: Tilstedeværelse af typiske hjertesvigt-symptomer/-tegn, ledsaget af enten nedsat venstre ventrikel-ejektionsfraktion (HFrEF, LVEF < 40%), let nedsat venstre ventrikel-ejektionsfraktion (HFmrEF, LVEF 40-49%), eller bevaret venstre ventrikel-ejektionsfraktion med forhøjet NT-proBNP og strukturelle hjertesygdomsændringer (HFpEF, LVEF ≥ 50%);
  2. Forventet overlevelse på mindre end 3 måneder;
  3. Patienter med svær nyreinsufficiens (Ccr < 30 mL/min) eller dem, der gennemgår dialysebehandling;
  4. Hjertedysfunktion forårsaget af forskellige reversible sekundære årsager, inklusive hyperthyroid hjertesygdom, anemisk hjertesygdom og ukorrigeret medfødt hjertesygdom;
  5. Tilstedeværelse af indikationer for pacemaker-implantation uden efterfølgende enhedsplacering;
  6. Patienter med kronisk obstruktiv lungesygdom (KOL) kompliceret af type III respirationssvigt;
  7. Specielle befolkningsgrupper såsom patienter med psykisk sygdom.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Control Group
Participants in this arm will receive usual chronic disease management according to the National Basic Public Health Service requirements.
Andet: Usual Care
Participants in the control group will receive usual chronic disease management according to the National Basic Public Health Service requirements. Usual care includes routine follow-up, general health education, medication registration, and standard referral procedures provided by local primary care providers. Participants will not receive the structured village-doctor led integrated care program.
Eksperimentel: Intervention Group
The intervention group will receive a village doctor-led integrated management program supported by telemedicine, guideline-based training, and a simplified exercise-based cardiac rehabilitation component, aiming to prevent incident heart failure in elderly rural patients with atrial fibrillation who have preserved cardiac function.
Andet: Village-Doctor Led Integrated Care
  1. Village doctors will conduct monthly follow-up, including symptom assessment, vital-sign monitoring, medication adherence support, cardiovascular risk-factor management, health education, and referral when needed.
  2. Village doctors will provide AF management based on the ABC pathway and simplified home-based exercise rehabilitation education.
  3. When clinical deterioration or management difficulties occur, village doctors may use a remote care platform to obtain cardiology specialist consultation and treatment recommendations within 24 hours.
  4. Village doctors will receive standardized training on AF management, anticoagulation, rate/rhythm control, and cardiovascular risk-factor management.
  5. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, exercise rehabilitation, and recognition of warning signs.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite Cardiovascular Outcome
Tidsramme: Baseline to 36 months
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.
Baseline to 36 months
Incidence of Asymptomatic Left Ventricular Dysfunction With or Without Heart Failure
Tidsramme: Baseline to 48 months
Incidence of asymptomatic left ventricular dysfunction with or without heart failure, assessed by clinical evaluation, NT-proBNP, and echocardiographic evidence of cardiac dysfunction.
Baseline to 48 months
Change in Life's Essential 8 Cardiovascular Health Score
Tidsramme: Baseline to 12 months
Mean change in Life's Essential 8 cardiovascular health score from baseline to 12 months. The score includes diet, physical activity, nicotine exposure, sleep health, body mass index, non-HDL cholesterol, blood glucose, and blood pressure.
Baseline to 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiovascular Death
Tidsramme: 12 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular death
12 months after baseline
Cardiovascular Hospitalization
Tidsramme: 12 months after baseline
Hospitalization due to cardiovascular or neurological diseases at township-level or higher hospitals, including heart failure, cardiac arrhythmia, acute coronary syndrome, hypertensive emergency or urgency, ischemic or hemorrhagic stroke, and transient ischemic attack.
12 months after baseline
Emergency Visit for Cardiovascular Events
Tidsramme: 12 months after baseline
Incidence of emergency visits for cardiovascular events, including exacerbation of heart failure or acute coronary syndrome.
12 months after baseline
ischemic or hemorrhagic Stroke
Tidsramme: 12 months after baseline
All strokes: ischemic or hemorrhagic Stroke
12 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway of integrated AF care
Tidsramme: 12 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
12 month after baseline
Cardiovascular Death
Tidsramme: 36 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime
36 months after baseline
Ischemic or hemorrhagic Stroke
Tidsramme: 36 months after baseline
All strokes: ischemic or hemorrhagic Stroke
36 months after baseline
Worsening of heart failure or acute coronary syndrome
Tidsramme: 36 months after baseline
A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions
36 months after baseline
Emergency visit due to AF
Tidsramme: 36 months after baseline
Emergency visit due to AF
36 months after baseline
All-cause mortality
Tidsramme: 36 months after baseline
all-cause death
36 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
Tidsramme: 36 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
36 month after baseline
Cardiovascular Death
Tidsramme: 48 months after baseline
Cardiovascular death was defined as death attributable to myocardial infarction, heart failure, arrhythmia, cardiac perforation or tamponade, or other deaths of cardiac origin. Death caused by ischemic stroke, hemorrhagic stroke, peripheral embolism, and pulmonary embolism was also classified as cardiovascular deathTime
48 months after baseline
Ischemic or hemorrhagic Stroke
Tidsramme: 48 months after baseline
All strokes: ischemic or hemorrhagic Stroke
48 months after baseline
Worsening of heart failure or acute coronary syndrome
Tidsramme: 48 months after baseline
A worsening of heart failure or acute coronary syndrome was defined as the need to be hospitalized or have an emergency visit in conjunction with these conditions
48 months after baseline
Emergency visit due to AF
Tidsramme: 48 months after baseline
Emergency visit due to AF
48 months after baseline
All-cause mortality
Tidsramme: 48 months after baseline
all-cause death
48 months after baseline
The proportion of patients who met all the three criteria for the ABC pathway
Tidsramme: 48 month after baseline
The 'A' criterion referred to stroke prevention or anticoagulation. 'A criterion compliant' implies that either appropriate non-vitamin K antagonist oral anticoagulant (NOACs) use, or warfarin was used with a time in the therapeutic range (TTR) >65%. Patients who were not properly treated with OACs are considered as 'A non-compliant'. The 'B' criterion referred to better symptom control with patient-centered decisions on rate or rhythm control. Patients with an EHRA score of I or II are considered to have good control of AF symptoms ('B compliant'). On the contrary, those with an EHRA score of III or IV were defined as 'B non-compliant', which means their symptoms were insufficiently controlled. The 'C' criterion stands for optimal management of cardiovascular risk factors and other comorbidities. 'C criterion compliant' implies that all the considered risk factors and comorbidities were well controlled or optimally treated. Otherwise, patients were considered as 'C non-compliant'
48 month after baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jiangsu Taizhou People's Hospital

Samarbejdspartnere

The First Affiliated Hospital with Nanjing Medical University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. juli 2030

Studieafslutning (Anslået)

1. juli 2030

Datoer for studieregistrering

Først indsendt

16. marts 2026

Først indsendt, der opfyldte QC-kriterier

19. marts 2026

Først opslået (Faktiske)

25. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LSKY 2025-191-01，2026-SR-221

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner