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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who have started at first time on Jardiance® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE® | Drug | JARDIANCE® film-coated tablets 10mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rates of patients with adverse events | 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. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
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Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Medical Center | Anyang-si, Gyeonggi-do | 14068 | South Korea | |||
| Inje University Busan Paik Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 29, 2026 | |
| Reset | May 20, 2026 | |
| Release | Jun 13, 2026 |
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| Occurrence of cardiovascular death after 12 weeks of treatment | 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 from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments | at baseline, at week 24 |
| Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline | at baseline, at week 12 |
| 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 |
| 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 |
| Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment | 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 |
| 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 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 |
| Change from baseline in body weight after 12 weeks of treatment | at baseline, at week 12 |
| Change from baseline in body weight after 24 weeks of treatment | 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 |
| Investigator's overall effectiveness evaluation after 12 weeks of treatment |
| at week 12 |
| Investigator's overall effectiveness evaluation after 24 weeks of treatment |
| at week 24 |
| Busan |
| 47392 |
| South Korea |
| Inje University Haeundae Paik Hospital | Busan | 48108 | South Korea |
| Pusan National University Hospital | Busan | 49241 | South Korea |
| Pusan National University Yangsan Hospital | Busan | 50612 | South Korea |
| Kangwon National University Hospital | Chuncheon-si, Gangwon-do | 24289 | South Korea |
| Kyungpook National University Hospital | Daegu | 41944 | South Korea |
| Yeungnam University Medical Center | Daegu | 42415 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Dongguk University Medical Center | Goyang-si, Gyeonggi-do | 10326 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang-si, Gyeonggi-do | 10380 | South Korea |
| Chonnam National University Hospital) | Gwangju | 61469 | South Korea |
| Jeonbuk National University Hospital | Jeonju-si, Jeollabuk-do | 54907 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| VHS Medical Center | Seoul | 05368 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul | 06591 | South Korea |
| Seoul National University Boramae Medical Center | Seoul | 07061 | South Korea |
| The Catholic University of Korea, Uijeongbu ST. Mary's Hospital | Uijeongbu-si, Gyeonggi-do | 11765 | South Korea |
| Unrelease | Jun 23, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2026 | May 20, 2026 | |||
| Jun 13, 2026 | Jun 23, 2026 | |||
| Jun 23, 2026 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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