N/A
N=1,166
Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT05262764 ↗Enrolled (actual)
1,166
Serious AEs
12.7%
Results posted
Aug 2025
Primary outcome: Primary: Number of Subjects With Adverse Drug Reactions (ADRs) — 61 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- JARDIANCE® (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Drug Reactions (ADRs) |
61 | — |
| SECONDARY Incidence of All-cause Death |
3.01 | — |
| SECONDARY Incidence of Cardiovascular Death |
0.90 | — |
| SECONDARY Incidence of Hospitalizations for Heart Failure |
2.53 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Patients with chronic heart failure (CHF) failure who are prescribed with JARDIANCE® Tablets in Japan
- Patients who have never been treated with Empagliflozin (including treatment for type 2 diabetes mellitus (T2DM)) before enrolment
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT05262764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.