Jardiance® Post Marketing Surveillance (PMS) hos koreanske patienter med kronisk hjertesvigt
En regulatorisk ikke-interventionsundersøgelse for at overvåge sikkerheden og effektiviteten af Jardiance® (Empagliflozin, 10 mg) hos koreanske patienter med kronisk hjertesvigt (NYHA klasse II-IV)
Studieoversigt
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Anyang-si, Gyeonggi-do, Sydkorea, 14068
- Hallym University Medical Center
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Busan, Sydkorea, 49241
- Pusan National University Hospital
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Busan, Sydkorea, 47392
- Inje University Busan Paik Hospital
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Busan, Sydkorea, 48108
- Inje university Haeundae Paik Hospital
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Busan, Sydkorea, 50612
- Pusan National University Yangsan Hospital
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Chuncheon-si, Gangwon-do, Sydkorea, 24289
- Kangwon National University Hospital
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Daegu, Sydkorea, 42415
- Yeungnam University Medical Center
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Daegu, Sydkorea, 41944
- Kyungpook National University Hospital
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Daejeon, Sydkorea, 35015
- Chungnam National University Hospital
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Goyang-si, Gyeonggi-do, Sydkorea, 10326
- dongguk University Medical Center
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Goyang-si, Gyeonggi-do, Sydkorea, 10380
- Inje University Ilsan Paik Hospital
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Gwangju, Sydkorea, 61469
- Chonnam National University Hospital)
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Jeonju-si, Jeollabuk-do, Sydkorea, 54907
- Jeonbuk National University Hospital
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Seoul, Sydkorea, 05505
- Asan Medical Center
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Seoul, Sydkorea, 06351
- Samsung Medical Center
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Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Sydkorea, 07061
- Seoul National University Boramae Medical Center
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Seoul, Sydkorea, 02841
- Korea University Anam Hospital
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Seoul, Sydkorea, 05368
- VHS medical center
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Uijeongbu-si, Gyeonggi-do, Sydkorea, 11765
- The Catholic University of Korea, Uijeongbu St. Mary's Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Patienter, der første gang er startet på Jardiance® i overensstemmelse med den godkendte etiket i Korea for hjertesvigt (HF)
- Kronisk hjertesvigt (New York Heart Association (NYHA) klasse II-IV)
- Alder ≥ 19 år ved indskrivning
- Patienter, der har skrevet under på datafrigivelsessamtykkeformularen
Ekskluderingskriterier:
- Patienter med tidligere eksponering for Jardiance®
- Kendt allergi eller overfølsomhed over for aktive ingredienser empagliflozin eller over for et eller flere af hjælpestofferne
- Patienter med type 1-diabetes eller med tidligere diabetisk ketoacidose (DKA)
- Patient med nedsat nyrefunktion med estimeret glomerulær filtrationshastighed (eGFR) < 20 ml/min/1,73 m²
- Patienter med sjældne arvelige tilstande med galactoseintolerance, Lapp lactase-mangel eller glucose-galactose malabsorption
- Patient, der er gravid eller ammer, eller som planlægger at blive gravid under forsøget
- Patienter, for hvem empagliflozin er kontraindiceret i henhold til Jardiance®s lokale etiket
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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).
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JARDIANCE® filmovertrukne tabletter 10 mg
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Patients With Adverse Events (AEs)
Tidsramme: Up to 407 days.
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Number of patients with adverse events (AEs) is reported.
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Up to 407 days.
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Number of Patients With Unexpected Adverse Events
Tidsramme: Up to 407 days.
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Number of patients with unexpected adverse events is reported.
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Up to 407 days.
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Number of Patients With Unexpected Adverse Drug Reaction
Tidsramme: Up to 407 days.
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Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
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Up to 407 days.
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Number of Patients With Serious Adverse Events
Tidsramme: Up to 407 days.
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Number of patients with serious adverse events is reported.
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Up to 407 days.
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Number of Patients With Serious Adverse Drug Reaction
Tidsramme: Up to 407 days.
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Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.
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Up to 407 days.
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Number of Patients With Drug-related Adverse Events
Tidsramme: Up to 407 days.
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Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.
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Up to 407 days.
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Number of Patients With Non-serious Adverse Drug Reaction
Tidsramme: Up to 407 days.
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Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.
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Up to 407 days.
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Number of Patients With Adverse Event of Special Interest
Tidsramme: Up to 407 days.
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Number of patients with adverse event of special interest is reported.
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Up to 407 days.
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Number of Patients With Adverse Events Leading to Discontinuation
Tidsramme: Up to 407 days.
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Number of patients with adverse events leading to discontinuation is reported.
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Up to 407 days.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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.
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Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Tidsramme: Data collected at week 12 and week 24.
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Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.
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Data collected at week 12 and week 24.
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Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Tidsramme: At baseline and at week 12.
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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.
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Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Tidsramme: At baseline and at week 24.
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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.
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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.
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Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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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.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.
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Data collected at baseline (visit 1), week 12 and week 24.
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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.
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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.
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Data collected at baseline (visit 1), week 12 and week 24.
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Samarbejdspartnere og efterforskere
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Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1245-0276
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