Heart Failure
Conditions
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.
Interventions
DRUGJARDIANCE®
JARDIANCE® film-coated tablets 10mg
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have started at first time on Jardiance® in accordance with the approved label in Korea for heart failure (HF) * Chronic heart failure (New York Heart Association (NYHA) class II-IV) * Age ≥ 19 years at enrolment * Patients who have signed on the data release consent form
Exclusion criteria
* Patients with previous exposure to Jardiance® * Known allergy or hypersensitivity to active ingredients empagliflozin or to any of the excipients * Patients with type 1 diabetes or with prior history of diabetic ketoacidosis (DKA) * Patient with renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 20 mL/min/1.73 m² * Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption * Patient who are pregnant or are nursing or who plan to become pregnant while in the trial * Patients for whom empagliflozin is contraindicated according local label of Jardiance®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Adverse Events (AEs) | Up to 407 days. | Number of patients with adverse events (AEs) is reported. |
| Number of Patients With Unexpected Adverse Events | Up to 407 days. | Number of patients with unexpected adverse events is reported. |
| Number of Patients With Unexpected Adverse Drug Reaction | Up to 407 days. | Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported. |
| Number of Patients With Serious Adverse Events | Up to 407 days. | Number of patients with serious adverse events is reported. |
| Number of Patients With Serious Adverse Drug Reaction | Up to 407 days. | Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported. |
| Number of Patients With Drug-related Adverse Events | Up to 407 days. | Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported. |
| Number of Patients With Non-serious Adverse Drug Reaction | Up to 407 days. | Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported. |
| Number of Patients With Adverse Event of Special Interest | Up to 407 days. | Number of patients with adverse event of special interest is reported. |
| Number of Patients With Adverse Events Leading to Discontinuation | Up to 407 days. | Number of patients with adverse events leading to discontinuation is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline | 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. |
| Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment | Data collected at week 12 and week 24. | Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported. |
| Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment | 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. |
| Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment | 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. |
| Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline | 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. |
| Changes in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) at 12 Weeks and 24 Weeks Compared to Baseline | 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. |
| Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment | 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. |
| Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) After 12 Weeks and 24 Weeks of Treatment | 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. |
| Change From Baseline in Body Weight After 12 Weeks and 24 Weeks of Treatment | 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. |
| Change From Baseline in Systolic Blood Pressure (SBP) After 12 Weeks and 24 Weeks of Treatment | 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. |
| Change From Baseline in Diastolic Blood Pressure (DBP) After 12 Weeks and 24 Weeks of Treatment | 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. |
| The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment | 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". |
Countries
South Korea
Participant flow
Recruitment details
This was a single-arm, open-label, multicenter, observational, non-interventional study to monitor the safety profile and efficacy of Jardiance® in Korean patients with Chronic Heart Failure (New York Heart Association (NYHA) class II-IV).
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 676 enrolled subjects, 47 subjects were not included in the safety set.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 14.68 |
| Sex: Female, Male Female | 241 Participants |
| Sex: Female, Male Male | 388 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 5 / 629 |
| other Total, other adverse events | 0 / 629 |
| serious Total, serious adverse events | 33 / 629 |
Outcome results
None listed