Jardiance® Post Marketing Surveillance (PMS) em pacientes coreanos com insuficiência cardíaca crônica
Um estudo não intervencional de exigência regulamentar para monitorar a segurança e a eficácia de Jardiance® (empagliflozina, 10 mg) em pacientes coreanos com insuficiência cardíaca crônica (NYHA Classe II-IV)
Visão geral do estudo
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Anyang-si, Gyeonggi-do, Coréia do Sul, 14068
- Hallym University Medical Center
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Busan, Coréia do Sul, 49241
- Pusan National University Hospital
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Busan, Coréia do Sul, 47392
- Inje University Busan Paik Hospital
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Busan, Coréia do Sul, 48108
- Inje University Haeundae Paik Hospital
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Busan, Coréia do Sul, 50612
- Pusan National University Yangsan Hospital
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Chuncheon-si, Gangwon-do, Coréia do Sul, 24289
- Kangwon National University Hospital
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Daegu, Coréia do Sul, 42415
- Yeungnam University Medical Center
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Daegu, Coréia do Sul, 41944
- Kyungpook National University Hospital
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Daejeon, Coréia do Sul, 35015
- Chungnam National University Hospital
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Goyang-si, Gyeonggi-do, Coréia do Sul, 10326
- dongguk University Medical Center
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Goyang-si, Gyeonggi-do, Coréia do Sul, 10380
- Inje University Ilsan Paik Hospital
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Gwangju, Coréia do Sul, 61469
- Chonnam National University Hospital)
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Jeonju-si, Jeollabuk-do, Coréia do Sul, 54907
- Jeonbuk National University Hospital
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Seoul, Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Coréia do Sul, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Coréia do Sul, 06591
- The Catholic University of Korea, Seoul St. Mary's Hospital
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Seoul, Coréia do Sul, 07061
- Seoul National University Boramae Medical Center
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Seoul, Coréia do Sul, 02841
- Korea University Anam Hospital
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Seoul, Coréia do Sul, 05368
- VHS medical center
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Uijeongbu-si, Gyeonggi-do, Coréia do Sul, 11765
- The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
Critério de inclusão:
- Pacientes que iniciaram Jardiance® pela primeira vez de acordo com o rótulo aprovado na Coréia para insuficiência cardíaca (IC)
- Insuficiência cardíaca crônica (classe II-IV da New York Heart Association (NYHA))
- Idade ≥ 19 anos na inscrição
- Pacientes que assinaram o formulário de consentimento de liberação de dados
Critério de exclusão:
- Pacientes com exposição prévia ao Jardiance®
- Alergia ou hipersensibilidade conhecida aos ingredientes ativos empagliflozina ou a qualquer um dos excipientes
- Pacientes com diabetes tipo 1 ou com história prévia de cetoacidose diabética (CAD)
- Paciente com insuficiência renal com taxa de filtração glomerular estimada (TFGe) < 20 mL/min/1,73 m²
- Pacientes com condições hereditárias raras de intolerância à galactose, deficiência de Lapp lactase ou má absorção de glicose-galactose
- Paciente grávida ou amamentando ou que planeja engravidar durante o estudo
- Pacientes para os quais a empagliflozina é contraindicada de acordo com a bula local de Jardiance®
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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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® comprimidos revestidos por película 10 mg
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Patients With Adverse Events (AEs)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1245-0276
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Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
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