An observational study in Heart Failure, sponsored by Boehringer Ingelheim. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Boehringer Ingelheim · Observational
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic heart failure (CHF) under real-world use.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 1,200 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Japanese patients with chronic heart failure (CHF).
Exclusion Criteria:
Patients in Japan with chronic heart failure who were prescribed JARDIANCE® tablets and who were never treated with Empagliflozin before enrolment. Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS). Patients were observed for up to 52 weeks after start of the treatment or until discontinuation of administration.
Drug: JARDIANCE®
Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).
Also known as: empagliflozin
Number of Subjects With Adverse Drug Reactions (ADRs)
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
Time frame: Up to 52 weeks
Incidence of All-cause Death
Incidence of all-cause death.
Time frame: Up to 52 weeks
Incidence of Cardiovascular Death
Incidence of cardiovascular death.
Time frame: Up to 52 weeks
Incidence of Hospitalizations for Heart Failure
Incidence of hospitalizations for heart failure.
Time frame: Up to 52 weeks
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.
| Milestone | JARDIANCE® |
|---|---|
| Started | 1166 |
| Completed | 921 |
| Not completed | 245 |
| Withdrew: Adverse event | 78 |
| Withdrew: Withdrawal by subject | 21 |
| Withdrew: Improvement | 3 |
| Withdrew: Lost to follow-up | 29 |
| Withdrew: Untraceable for changing hospital | 66 |
| Withdrew: Other than listed | 41 |
| Withdrew: Other | 7 |
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).
| Participants | JARDIANCE® |
|---|---|
| Number of Subjects With Adverse Drug Reactions (ADRs) | 61 |
Incidence of all-cause death.
| Deaths per 100 person-years | JARDIANCE® |
|---|---|
| Incidence of All-cause Death | 3.01 (2.03 to 4.29) |
Incidence of cardiovascular death.
| Deaths per 100 person-years | JARDIANCE® |
|---|---|
| Incidence of Cardiovascular Death | 0.90 (0.41 to 1.71) |
Incidence of hospitalizations for heart failure.
| 1st Hospitalization per 100 person-years | JARDIANCE® |
|---|---|
| Incidence of Hospitalizations for Heart Failure | 2.53 (1.64 to 3.74) |
Collected over Up to 52 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| JARDIANCE® | 30/1,166 (2.6%) | 148/1,166 (12.7%) | 0/1,166 (0%) |
| Event | JARDIANCE® |
|---|---|
| Cardiac failureCardiac disorders | 58/1166 |
| Atrial fibrillationCardiac disorders | 7/1166 |
| COVID-19Infections and infestations | 6/1166 |
| PneumoniaInfections and infestations | 6/1166 |
| Cerebral infarctionNervous system disorders | 6/1166 |
| Cardiac failure chronicCardiac disorders | 5/1166 |
| Pneumonia aspirationInfections and infestations | 4/1166 |
| DehydrationMetabolism and nutrition disorders | 4/1166 |
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 4/1166 |
| Acute kidney injuryRenal and urinary disorders | 4/1166 |
Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.
| Age, Continuous(years) | JARDIANCE® |
|---|---|
| Mean | 74.9 ± 12.4 |
| Sex: Female, Male(Participants) | JARDIANCE® |
|---|---|
| Female | 455 |
| Male | 711 |
| Race and Ethnicity Not Collected(Participants) | JARDIANCE® |
|---|
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim