Heart FailureNCT05236673
Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
An observational study of Heart Failure, run by Boehringer Ingelheim at 21 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- JARDIANCE®
- Type of treatment
- Pill or oral medicine
- How many people
- 676 participants
- Where
- 21 sitesSouth Korea
- Study dates
- 28 Jul 2022to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.
Who may be able to join
- 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
Who cannot join
- 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®
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites
Hallym University Medical Center
Anyang-si, Gyeonggi-do, 14068
Inje University Busan Paik Hospital
Busan, 47392
Inje University Haeundae Paik Hospital
Busan, 48108
Pusan National University Hospital
Busan, 49241
Pusan National University Yangsan Hospital
Busan, 50612
Kangwon National University Hospital
Chuncheon-si, Gangwon-do, 24289
Kyungpook National University Hospital
Daegu, 41944
Yeungnam University Medical Center
Daegu, 42415
Chungnam National University Hospital
Daejeon, 35015
Dongguk University Medical Center
Goyang-si, Gyeonggi-do, 10326
Inje University Ilsan Paik Hospital
Goyang-si, Gyeonggi-do, 10380
Chonnam National University Hospital)
Gwangju, 61469
Jeonbuk National University Hospital
Jeonju-si, Jeollabuk-do, 54907
Korea University Anam Hospital
Seoul, 02841
Severance Hospital, Yonsei University Health System
Seoul, 03722
VHS Medical Center
Seoul, 05368
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, 06591
Seoul National University Boramae Medical Center
Seoul, 07061
The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, 11765
About this study
Official title: A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Jardiance® (Empagliflozin, 10mg) in Korean Patients With Chronic Heart Failure (NYHA Class II-IV)
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.
- Conditions
- Heart Failure
- Being tested
- JARDIANCE®
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JARDIANCE®Drug
Also called empagliflozin
JARDIANCE® film-coated tablets 10mg
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: JARDIANCE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AEs)
Number of patients with adverse events (AEs) is reported.
Measured: Up to 407 days.
Number of Patients With Unexpected Adverse Events
Number of patients with unexpected adverse events is reported.
Measured: Up to 407 days.
Number of Patients With Unexpected Adverse Drug Reaction
Number of patients with unexpected adverse drug reaction in JARDIANCE® treated patients is reported.
Measured: Up to 407 days.
Number of Patients With Serious Adverse Events
Number of patients with serious adverse events is reported.
Measured: Up to 407 days.
Number of Patients With Serious Adverse Drug Reaction
Number of patients with serious adverse drug reaction in JARDIANCE® treated patients is reported.
Measured: Up to 407 days.
Number of Patients With Drug-related Adverse Events
Number of patients with drug-related adverse events in JARDIANCE® treated patients is reported.
Measured: Up to 407 days.
Number of Patients With Non-serious Adverse Drug Reaction
Number of patients with non-serious adverse drug reaction in JARDIANCE® treated patients is reported.
Measured: Up to 407 days.
Number of Patients With Adverse Event of Special Interest
Number of patients with adverse event of special interest is reported.
Measured: Up to 407 days.
Number of Patients With Adverse Events Leading to Discontinuation
Number of patients with adverse events leading to discontinuation is reported.
Measured: Up to 407 days.
Secondary outcomes (12)
Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Occurrence of hospitalisation for heart failure (first and recurrent) after 12 weeks and 24 weeks of treatment from baseline was reported.
Measured: Data collected at baseline (visit 1), week 12 and week 24.
Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Occurrence of cardiovascular death after 12 weeks and 24 weeks of treatment was reported.
Measured: Data collected at week 12 and week 24.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
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.
Measured: At baseline and at week 12.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
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.
Measured: At baseline and at week 24.
Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline
Changes in Ejection Fraction (EF) at 12 weeks and 24 weeks compared to baseline was reported.
Measured: 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
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.
Measured: Data collected at baseline (visit 1), week 12 and week 24.
Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment
Changes in Glycosylated Hemoglobin (HbA1c) after 12 weeks and 24 weeks of treatment was reported.
Measured: 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
Change from baseline in Estimated Glomerular Filtration Rate (eGFR) after 12 weeks and 24 weeks of treatment was reported.
Measured: 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
Change from baseline in Body weight after 12 weeks and 24 weeks of treatment was reported.
Measured: 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
Change from baseline in Systolic Blood Pressure (SBP) after 12 weeks and 24 weeks of treatment was reported.
Measured: 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
Change from baseline in Diastolic Blood Pressure (DBP) after 12 weeks and 24 weeks of treatment was reported.
Measured: Data collected at baseline (visit 1), week 12 and week 24.
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
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.
- Improved: If determined as there is any effect of maintaining or improving disease related factors.
- Unchanged: If disease related factors have not been changed compared with before administration and not determined as there is any effect of maintaining symptoms.
- Worsening: If disease related factors are worse than before administration. 'Improved' and 'Unchanged' are assessed as "Effective" and 'Worsening' is assessed as "Ineffective".
Measured: Data collected at baseline (visit 1), week 12 and week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start28 Jul 2022
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236673
- Sponsor's protocol ID
- 1245-0276
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2022
- Last updated
- 10 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Jardiance® (Empagliflozin, 10mg) in Korean Patients With Chronic Heart Failure (NYHA Class II-IV)
- ClinicalTrials.gov ID
- NCT05236673
- Acronym / sponsor ID
- 1245-0276
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 676 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2022 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Posted 10 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JARDIANCE® treated patients | – | Drug: JARDIANCE®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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JARDIANCE®Also: empagliflozinJARDIANCE® film-coated tablets 10mg | Drug | JARDIANCE® treated patients |
Primary outcome
Number of Patients With Adverse Events (AEs)
Time frame: Up to 407 days.
Number of patients with adverse events (AEs) is reported.
Number of Patients With Unexpected Adverse Events
Time frame: Up to 407 days.
Number of patients with unexpected adverse events is reported.
Number of Patients With Unexpected Adverse Drug Reaction
Time frame: 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
Time frame: Up to 407 days.
Number of patients with serious adverse events is reported.
Number of Patients With Serious Adverse Drug Reaction
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 407 days.
Number of patients with adverse event of special interest is reported.
Number of Patients With Adverse Events Leading to Discontinuation
Time frame: Up to 407 days.
Number of patients with adverse events leading to discontinuation is reported.
12 secondary outcomes
Occurrence of Hospitalisation for Heart Failure (First and Recurrent) After 12 Weeks and 24 Weeks of Treatment From Baseline
Time frame: Data collected at baseline (visit 1), week 12 and week 24.
Occurrence of Cardiovascular Death After 12 Weeks and 24 Weeks of Treatment
Time frame: Data collected at week 12 and week 24.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 12 Weeks of Treatment
Time frame: At baseline and at week 12.
Changes From Baseline in New York Heart Association (NYHA) Functional Class After 24 Weeks of Treatment
Time frame: At baseline and at week 24.
Changes in Ejection Fraction (EF) at 12 Weeks and 24 Weeks Compared to Baseline
Time frame: 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
Time frame: Data collected at baseline (visit 1), week 12 and week 24.
Changes in Glycosylated Hemoglobin (HbA1c) After 12 Weeks and 24 Weeks of Treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Data collected at baseline (visit 1), week 12 and week 24.
The Result of Investigator's Overall Evaluation After 12 Weeks and 24 Weeks of Treatment
Time frame: Data collected at baseline (visit 1), week 12 and week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boehringer Ingelheim at 21 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (AEs) (time frame: Up to 407 days.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.