Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
- Registration Number
- NCT05236673
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 610
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients who have started at first time on Jardiance® JARDIANCE® -
- Primary Outcome Measures
Name Time Method Incidence rates of patients with adverse events up to 24 weeks Adverse events will include: Adverse events, unexpected adverse events, unexpected adverse drug reaction, serious adverse events, serious adverse drug reaction, drug-related adverse events, non-serious adverse drug reaction, adverse event of special interest, adverse events leading to discontinuation.
- Secondary Outcome Measures
Name Time Method Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline at week 12 Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline at week 24 Changes in ejection fraction (EF) (if available) at 24 weeks compared to baseline at baseline, at week 24 Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 12 weeks compared to baseline at baseline, at week 12 Occurrence of cardiovascular death after 12 weeks of treatment at week 12 Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline at baseline, at week 12 Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment at baseline, at week 12 Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 12 weeks of treatment at baseline, at week 12 Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 24 weeks of treatment at baseline, at week 24 Investigator's overall effectiveness evaluation after 24 weeks of treatment at week 24 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. Aggravated: If disease related factors are worse than before administration.
4. Unassessable: If it cannot be determined due to insufficient information collected. (Even though there are any objective indicators present, it is possible to belong to this grade.) 'Improved' is assessed as "Effective", 'Unchanged' and 'Aggravated' are assessed as "Ineffective".Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment at baseline, at week 12 Change from baseline in body weight after 12 weeks of treatment at baseline, at week 12 Occurrence of cardiovascular death after 24 weeks of treatment at week 24 Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments at baseline, at week 12 Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 24 weeks compared to baseline at baseline, at week 24 Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 12 weeks of treatment at baseline, at week 12 Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 24 weeks of treatment at baseline, at week 24 Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments at baseline, at week 24 Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment at baseline, at week 24 Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment at baseline, at week 24 Change from baseline in body weight after 24 weeks of treatment at baseline, at week 24 Investigator's overall effectiveness evaluation after 12 weeks of treatment at week 12 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. Aggravated: If disease related factors are worse than before administration.
4. Unassessable: If it cannot be determined due to insufficient information collected. (Even though there are any objective indicators present, it is possible to belong to this grade.) 'Improved' is assessed as "Effective", 'Unchanged' and 'Aggravated' are assessed as "Ineffective".
Trial Locations
- Locations (21)
Hallym University Medical Center
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Busan, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Busan, Korea, Republic of
Kangwon National University Hospital
🇰🇷Chuncheon-si, Gangwon-do, Korea, Republic of
Kyungpook National University Hospital
🇰🇷Daegu, Korea, Republic of
Yeungnam University Medical Center
🇰🇷Daegu, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Dongguk University Medical Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hospital)
🇰🇷Gwangju, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju-si, Jeollabuk-do, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul ST. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
🇰🇷Uijeongbu-si, Gyeonggi-do, Korea, Republic of