Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)
Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan
1 other identifier
observational
1,200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 28, 2024
CompletedResults Posted
Study results publicly available
August 6, 2025
CompletedMarch 24, 2026
March 1, 2026
2.2 years
March 1, 2022
June 27, 2025
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Up to 52 weeks
Secondary Outcomes (3)
Incidence of All-cause Death
Up to 52 weeks
Incidence of Cardiovascular Death
Up to 52 weeks
Incidence of Hospitalizations for Heart Failure
Up to 52 weeks
Study Arms (1)
JARDIANCE®
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.
Interventions
Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).
Eligibility Criteria
Japanese patients with chronic heart failure (CHF).
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boehringer Ingelheimlead
- Eli Lilly and Companycollaborator
Study Sites (1)
Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, 1416017, Japan
Related Publications (1)
Yamamoto K, Naito Y, Watanabe S. Safety and effectiveness of empagliflozin in Japanese patients with heart failure: a 1-year post-marketing surveillance study stratified by age. Expert Opin Drug Saf. 2025 Jun 18:1-9. doi: 10.1080/14740338.2025.2519835. Online ahead of print.
PMID: 40512403DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Since this surveillance was an observational, non-interventional study, it lacked the methodological rigour of a randomised controlled trial. The study was conducted in an unblinded manner and without controls.
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2022
First Posted
March 2, 2022
Study Start
April 15, 2022
Primary Completion
June 21, 2024
Study Completion
June 28, 2024
Last Updated
March 24, 2026
Results First Posted
August 6, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- 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.
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.