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Jardiance® Post Marketing Surveillance (PMS) hos koreanske pasienter med kronisk hjertesvikt

23. juni 2026 oppdatert av: Boehringer Ingelheim

En regulatorisk ikke-intervensjonsstudie for å overvåke sikkerheten og effektiviteten til Jardiance® (Empagliflozin, 10 mg) hos koreanske pasienter med kronisk hjertesvikt (NYHA klasse II-IV)

Hovedmålet med denne studien er å overvåke sikkerhetsprofilen til Jardiance® hos koreanske pasienter med kronisk hjertesvikt (New York Heart Association (NYHA) klasse II-IV) i en rutinemessig klinisk setting.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

676

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sør -Korea
      • Anyang-si, Gyeonggi-do, Sør -Korea, 14068
        • Hallym University Medical Center
      • Busan, Sør -Korea, 49241
        • Pusan National University Hospital
      • Busan, Sør -Korea, 47392
        • Inje University Busan Paik Hospital
      • Busan, Sør -Korea, 48108
        • Inje University Haeundae Paik Hospital
      • Busan, Sør -Korea, 50612
        • Pusan National University Yangsan Hospital
      • Chuncheon-si, Gangwon-do, Sør -Korea, 24289
        • Kangwon National University Hospital
      • Daegu, Sør -Korea, 42415
        • Yeungnam University Medical Center
      • Daegu, Sør -Korea, 41944
        • Kyungpook National University Hospital
      • Daejeon, Sør -Korea, 35015
        • Chungnam National University Hospital
      • Goyang-si, Gyeonggi-do, Sør -Korea, 10326
        • dongguk University Medical Center
      • Goyang-si, Gyeonggi-do, Sør -Korea, 10380
        • Inje University Ilsan Paik Hospital
      • Gwangju, Sør -Korea, 61469
        • Chonnam National University Hospital)
      • Jeonju-si, Jeollabuk-do, Sør -Korea, 54907
        • Jeonbuk National University Hospital
      • Seoul, Sør -Korea, 05505
        • Asan Medical Center
      • Seoul, Sør -Korea, 06351
        • Samsung Medical Center
      • Seoul, Sør -Korea, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Sør -Korea, 06591
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Sør -Korea, 07061
        • Seoul National University Boramae Medical Center
      • Seoul, Sør -Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Sør -Korea, 05368
        • VHS medical center
      • Uijeongbu-si, Gyeonggi-do, Sør -Korea, 11765
        • The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Pasienter diagnostisert med kronisk hjertesvikt (New York Heart Association (NYHA) klasse II-IV) i Korea.

Beskrivelse

Inklusjonskriterier:

  • Pasienter som har startet første gang med Jardiance® i henhold til den godkjente etiketten i Korea for hjertesvikt (HF)
  • Kronisk hjertesvikt (New York Heart Association (NYHA) klasse II-IV)
  • Alder ≥ 19 år ved påmelding
  • Pasienter som har skrevet under på samtykkeskjemaet for datafrigivelse

Ekskluderingskriterier:

  • Pasienter med tidligere eksponering for Jardiance®
  • Kjent allergi eller overfølsomhet overfor virkestoffene empagliflozin eller overfor noen av hjelpestoffene
  • Pasienter med type 1 diabetes eller med tidligere diabetisk ketoacidose (DKA)
  • Pasient med nedsatt nyrefunksjon med estimert glomerulær filtreringshastighet (eGFR) < 20 ml/min/1,73 m²
  • Pasienter med sjeldne arvelige tilstander med galaktoseintoleranse, Lapp lactase-mangel eller glukose-galaktose malabsorpsjon
  • Pasient som er gravid eller ammer, eller som planlegger å bli gravid under forsøket
  • Pasienter som empagliflozin er kontraindisert for i henhold til Jardiance®s lokale merkelapp

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
JARDIANCE® treated patients
Patients in Korea with chronic heart failure who were prescribed JARDIANCE® (Empagliflozin) tablets and who were never treated with Empagliflozin before enrolment (including treatment for type 2 diabetes mellitus).
Legemiddel: JARDIANCE®
JARDIANCE® filmdrasjerte tabletter 10 mg
Andre navn:
  • empagliflozin

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Patients With Adverse Events (AEs)
Tidsramme: Up to 407 days.
Number of patients with adverse events (AEs) is reported.
Up to 407 days.
Number of Patients With Unexpected Adverse Events
Tidsramme: Up to 407 days.
Number of patients with unexpected adverse events is reported.
Up to 407 days.
Number of Patients With Unexpected Adverse Drug Reaction
Tidsramme: Up to 407 days.
Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
Up to 407 days.
Number of Patients With Serious Adverse Events
Tidsramme: Up to 407 days.
Number of patients with serious adverse events is reported.
Up to 407 days.
Number of Patients With Serious Adverse Drug Reaction
Tidsramme: Up to 407 days.
Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.
Up to 407 days.
Number of Patients With Drug-related Adverse Events
Tidsramme: Up to 407 days.
Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.
Up to 407 days.
Number of Patients With Non-serious Adverse Drug Reaction
Tidsramme: Up to 407 days.
Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.
Up to 407 days.
Number of Patients With Adverse Event of Special Interest
Tidsramme: Up to 407 days.
Number of patients with adverse event of special interest is reported.
Up to 407 days.
Number of Patients With Adverse Events Leading to Discontinuation
Tidsramme: Up to 407 days.
Number of patients with adverse events leading to discontinuation is reported.
Up to 407 days.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at week 12 and week 24.
Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.
Data collected at week 12 and week 24.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Tidsramme: At baseline and at week 12.

Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatment was reported.

The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 12 will also be presented.
At baseline and at week 12.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Tidsramme: At baseline and at week 24.

Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatment was reported.

The NYHA Classes of heart failure categorize patients with symptomatic or advanced heart failure based on their physical activity limitations. Class I patients present no limitation of physical activity, and ordinary physical activity does not cause fatigue, palpitations, or shortness of breath. Class II patients present a slight limitation of physical activity, characterized by fatigue, palpitations, shortness of breath, or chest pain as a result of ordinary physical activity. Class III patients are characterized by a marked limitation of physical activity, where less than ordinary activity causes fatigue, palpitations, shortness of breath, or chest pain. Class IV patients present symptoms of heart failure at rest, where any physical activity causes further discomfort. Participants who remain in the same class as at baseline through week 24 will also be presented.
At baseline and at week 24.
Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Changes in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) at 12 weeks and 24 weeks compared to baseline was reported. The results are presented after natural log transformation.
Data collected at baseline (visit 1), week 12 and week 24.
Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.
Data collected at baseline (visit 1), week 12 and week 24.
Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.
Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.
Data collected at baseline (visit 1), week 12 and week 24.
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at baseline (visit 1), week 12 and week 24.

The result of investigator's overall evaluation at the final visit was reported. The final visit represents each patient's last assessment among Week 12 or Week 24.

For the final effectiveness evaluation, the three items (Improved, Unchanged, Worsening) are evaluated by the changes from baseline of the NYHA Class at the end of last visit.

  1. Improved: If determined as there is any effect of maintaining or improving disease related factors.
  2. Unchanged: If disease related factors have not been changed compared with before administration and not determined as there is any effect of maintaining symptoms.
  3. Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".
Data collected at baseline (visit 1), week 12 and week 24.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. juli 2022

Primær fullføring (Faktiske)

30. april 2025

Studiet fullført (Faktiske)

30. april 2025

Datoer for studieregistrering

Først innsendt

2. februar 2022

Først innsendt som oppfylte QC-kriteriene

2. februar 2022

Først lagt ut (Faktiske)

11. februar 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1245-0276

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Når kriteriene i avsnittet "Tidsramme" er oppfylt, kan forskere bruke følgende lenke https://www.mystudywindow.com/msw/datasharing å be om tilgang til de kliniske studiedokumentene angående denne studien, og etter en signert "Document Sharing Agreement".

Videre kan forskere be om tilgang til de kliniske studiedataene, for denne og andre listede studier, etter innsending av et forskningsforslag og i henhold til vilkårene som er skissert på nettstedet.

IPD-delingstidsramme

Etter at strukturerte resultater er lagt ut, fullføres alle regulatoriske aktiviteter i USA og EU for produktet og indikasjonen, og etter at hovedmanuskriptet er akseptert for publisering.

Tilgangskriterier for IPD-deling

For studiedokumenter - ved signering av en 'Dokumentdelingsavtale'. For studiedata - 1. etter innsending og godkjenning av forskningsforslaget (kontroller vil bli utført av sponsoren og/eller det uavhengige granskingspanelet, inkludert kontroll av at den planlagte analysen ikke konkurrerer med sponsorens publiseringsplan); 2. og ved signering av en juridisk avtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere