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Telemedicinsk integreret behandling af atrieflimren og hjertesvigt hos ældre patienter i landsbyklinikker

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

Telemedicinsk integreret behandling af atrieflimren og hjertesvigt hos ældre patienter i landsbyklinikker: MIRACLE-AF II cluster-randomiseret forsøg

Formålet med denne klynge-randomiserede kliniske undersøgelse er at evaluere et telemedicinsk, landsbylægeledt integreret behandlingsprogram for ældre (65-80 år), der har både atrieflimren (AF) og hjertesvigt (HF) på landklinikker i Kina. Den sigter mod at besvare, om det digitalt understøttede program forbedrer prognosen for hjertesvigt, vurderet ved MAGGIC-scoren, efter 12 måneder, og reducerer risikoen for sammensatte endepunktsbegivenheder, såsom kardiovaskulær død, slagtilfælde eller indlæggelse for hjertesvigt, over 36 måneder sammenlignet med konventionel rutinemæssig pleje. I denne undersøgelse vil landsbyklinikker blive tilfældigt tildelt enten interventionsgruppen eller kontrolgruppen. Deltagere i kontrolgruppen vil modtage konventionel rutinemæssig pleje og grundlæggende offentlige sundhedsydelser, mens deltagere i interventionsgruppen vil modtage et omfattende behandlingsprogram ledet af landsbylæger. Denne intervention inkluderer optimeret medicinbehandling vejledt af en digital sundhedsplatform med fjern ekspertstøtte, samt en struktureret multidimensionel livsstilsintervention med peer-støttegruppetræning, smarte bærbare enheders overvågning og personlig sundhedsuddannelse.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Atrieflimren (AF) og hjertesvigt (HF) forekommer hyppigt samtidigt og forstærker hinanden gensidigt, hvilket danner en "ond cirkel", der er særligt ødelæggende for ældre voksne. Ældre patienter med AF har en høj risiko for HF-progression, og AF-HF-sygdomssammenhæng er en central faktor for den langsigtede prognose. I landdistrikter i Kina står effektiv forebyggelse og langsigtet behandling over for praktiske flaskehalse, herunder utilstrækkelig tidlig HF-screening og utilstrækkelig intensitet af målrettet forebyggelse. Tidligere undersøgelser tyder på, at "procesorienteret" integration alene, såsom den standardiserede ABC-vej, muligvis er utilstrækkelig for landdistrikts-AF-patienter, hvor HF-risikoen er dominerende.

For at imødegå disse huller har MIRACLE-AF II-studiet til formål at etablere en model ledet af landsbylæger, der integrerer retningslinjestyret medicinsk behandling (GDMT) med multidimensionelle livsstilsinterventioner, understøttet af telemedicin og intelligent beslutningsstøtte. Ved at integrere tidlig HF-screening, medicintilgang og en skalerbar livsstilsintervention (herunder peer-gruppe-hjerterehabilitering, adfærdsundervisning og overvågning med smarte bærbare enheder) i en tele-understøttet arbejdsgang søger dette projekt at effektivt forbedre de kliniske resultater for ældre patienter.

Dette er et klynge-randomiseret kontrolleret forsøg udført i landdistrikter i Jiangsu-provinsen, Kina. Landsbyklinikker randomiseres i et 1:1-forhold til enten en digital intelligent integreret ledelsesgruppe (intervention) eller en konventionel ledelsesgruppe (kontrol). Studiet inkluderer fastboende i alderen 65 til 80 år med bekræftet AF og en dokumenteret historie eller screeningsbaseret diagnose af HF. Forsøget er opdelt i to faser: en 12-måneders opfølgning for at sammenligne HF-prognose-scoren (MAGGIC-score) mellem de to grupper, og en 36-måneders opfølgning for at sammenligne sammensatte slutpunktsbegivenheder, herunder kardiovaskulær død, iskæmisk eller hæmoragisk apopleksi, indlæggelse på grund af forværret HF eller akut koronarsyndrom (ACS), og akutte besøg for AF.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

942

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. Faste borgere med lokal husstandsregistrering på primærniveau i Jiangsu-provinsen, i alderen 65-80 år.
  2. Elektrokardiogram (EKG) bekræftelse af AF eller besiddelse af en diagnostisk attest for AF udstedt af en specialist.
  3. En dokumenteret historie med HF eller en diagnose af HF baseret på ekokardiografi og/eller NT-proBNP-screening, defineret ved tilstedeværelse af typiske HF-symptomer og/eller tegn, sammen med en af følgende: reduceret venstre ventrikel ejektionsfraktion (HFrEF; LVEF < 40%), let reduceret venstre ventrikel ejektionsfraktion (HFmrEF; LVEF 40-49%) eller bevaret venstre ventrikel ejektionsfraktion med forhøjet NT-proBNP og strukturelle hjerteforandringer (HFpEF; LVEF ≥ 50%, opfyldende mindst ét af følgende kriterier: LAV 40 ml/m², E/e' ≥ 15, eller TRV > 2,8 m/s).
  4. Forvaltning af en landsbyklinik nær deltagerens bopæl.
  5. Evne til at forstå undersøgelsesprocedurerne og give skriftlig informeret samtykke.

Eksklusionskriterier:

  1. Forventet levealder på mindre end 3 måneder.
  2. Svær nyreinsufficiens (Ccr < 30ml/min) eller igangværende dialysebehandling.
  3. Hjertesvigt sekundært til korrigerbare årsager, herunder hyperthyroid hjerte sygdom, anemisk hjerte sygdom eller ukorrigeret medfødt hjertefejl.
  4. Indikationer for pacemaker implantation uden at have gennemgået implantation.
  5. Kronisk obstruktiv lungesygdom (KOL) kompliceret af type II respirationssvigt.
  6. Specielle populationer, herunder patienter med psykiske sygdomme.

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
Eksperimentel: Intervention Group
Participants in this arm will receive village-doctor led integrated care for atrial fibrillation and heart failure. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles. Patients will receive structured self-management education focused on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
Andet: Village-Doctor Led Integrated Care
  1. Village doctors will conduct monthly follow-up, including clinical assessment, vital-sign monitoring, medication review, risk screening, health education, and referral when needed.
  2. For patients with clinical deterioration or treatment difficulties, village doctors may use a remote care platform to obtain specialist consultation and individualized recommendations.
  3. Village doctors will receive standardized training based on the AF ABC pathway and heart failure GDMT principles.
  4. Patients will receive structured education on medication adherence, symptom monitoring, lifestyle modification, and recognition of warning signs.
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
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in MAGGIC Heart Failure Risk Score
Tidsramme: Baseline to 12 months
A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status.
Baseline to 12 months
Composite Cardiovascular Endpoint
Tidsramme: 36 months after baseline
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.
36 months after baseline

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
GDMT medication utilization rate
Tidsramme: 12months after baseline
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 12 Months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.
12months 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
Change in MAGGIC Heart Failure Risk Score
Tidsramme: Baseline to 36 months
Description: A heart failure prognostic model integrating 13 key predictors, including age, LVEF, systolic blood pressure, BMI, serum creatinine, NYHA functional class, and medication status.
Baseline to 36 months
GDMT Score
Tidsramme: Baseline to 12 months
β-blockers are scored as 0, 1, or 2 points for no use, use at <50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at <50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines.
Baseline to 12 months
GDMT Score
Tidsramme: Baseline to 36 months
β-blockers are scored as 0, 1, or 2 points for no use, use at <50% of the target dose, or use at ≥50% of the target dose, respectively. For renin-angiotensin system inhibitors, no use is scored as 0 points; ACEI/ARB therapy at <50% or ≥50% of the target dose is scored as 1 or 2 points, respectively; and ARNI therapy at any dose is scored as 3 points. Mineralocorticoid receptor antagonists and SGLT2 inhibitors are each scored as 0 points when not used and 2 points when used at any dose. Ivabradine and vericiguat are each scored as 0 points when not used and 1 point when used at any dose. The scores for all medication classes are summed to obtain the total GDMT score, with a higher score indicating a greater degree of GDMT implementation. Target doses are determined according to the relevant heart failure guidelines.
Baseline to 36 months
GDMT medication utilization rate
Tidsramme: 36 months after baseline
The proportion of patients who are eligible for guideline-directed medical therapy (GDMT) and actually receive GDMT within 36 months. Single-class prescription rate: Prescription rate for a given GDMT drug class = (number of patients prescribed that drug class) / (number of patients eligible for that drug class) × 100%. At least one GDMT class prescription rate: At least one GDMT prescription rate = (number of patients prescribed at least one GDMT drug class) / (total number of patients eligible for GDMT) × 100%. Quadruple GDMT prescription rate: Quadruple therapy prescription rate = (number of patients simultaneously prescribed ARNI/ACEI/ARB + β-blocker + MRA + SGLT2 inhibitor) / (number of patients eligible for all four drug classes) × 100%.
36 months 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)

30. december 2029

Studieafslutning (Anslået)

30. december 2029

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. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LSKY 2025-192-01，2026-SR-177

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 .

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