Post Marketing Surveillance (PMS) of JARDIANCE in Chronic Heart Failure (CHF)

An observational study of Heart Failure, run by Boehringer Ingelheim at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Heart Failure
What is being tested?: JARDIANCE®
Type of treatment: Pill or oral medicine
How many people: 1,200 participants
Where: 1 siteJapan
Study dates: 15 Apr 2022to 28 Jun 2024
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Japanese patients with chronic heart failure (CHF).

Who may be able to join

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

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

Japan1 site

Nippon Boehringer Ingelheim Co., Ltd.
Tokyo, 1416017

Other trials in Japan

About this study

Official title: Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan

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.

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
Treatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).

Study groups in NCT05262764
Study group	Role	What they receive
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. Receives: Drug: JARDIANCE®

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Up to 52 weeks

Secondary outcomes (3)

Incidence of All-cause Death
Incidence of all-cause death.
Measured: Up to 52 weeks
Incidence of Cardiovascular Death
Incidence of cardiovascular death.
Measured: Up to 52 weeks
Incidence of Hospitalizations for Heart Failure
Incidence of hospitalizations for heart failure.
Measured: Up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 202228 Jun 2024

First posted2 Mar 2022
Study start15 Apr 2022
Primary completion21 Jun 2024
Study completion28 Jun 2024

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.
Publications (1)Papers the sponsor has linked to this study.
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: 1,200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05262764
Sponsor's protocol ID: 1245-0286
Status last verified: Mar 2026
First submitted: 1 Mar 2022
Last updated: 24 Mar 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.

Publications

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.
PubMed 40512403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post Marketing Surveillance on Long Term Drug Use of JARDIANCE® Tablets in Patients With Chronic Heart Failure in Japan
ClinicalTrials.gov ID: NCT05262764
Acronym / sponsor ID: 1245-0286
Conditions: Heart Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 1,200 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 15 Apr 2022 (actual)
Primary completion: 21 Jun 2024 (actual)
Study completion: 28 Jun 2024 (actual)
First posted: 2 Mar 2022 (actual)
Results: Posted 6 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
JARDIANCE®	–	Drug: 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Japanese patients with chronic heart failure (CHF).

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

None

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: empagliflozinTreatment was in accordance with the latest guidelines from The Japanese Circulation Society (JCS).	Drug	JARDIANCE®

Primary outcome

Number of Subjects With Adverse Drug Reactions (ADRs)
Time frame: Up to 52 weeks
Number of subjects with ADRs (focus on hypoglycaemia, the events relevant for volume depletion, influence of ketone body increased / ketoacidosis, renal impairment).

3 secondary outcomes

Incidence of All-cause Death
Time frame: Up to 52 weeks
Incidence of Cardiovascular Death
Time frame: Up to 52 weeks
Incidence of Hospitalizations for Heart Failure
Time frame: Up to 52 weeks

Results and safety

Results posted to the registry on 6 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
JARDIANCE®	1,166	921

Primary outcome: Number of Subjects With Adverse Drug Reactions (ADRs)

Time frame: Up to 52 weeks. Count of participants. Unit: Participants

Measure	JARDIANCE® n = 1166
Value	61

Population analysed: Safety set: all patients who didn't have important Protocol Deviations regarding safety and regulatory issues.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 52 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
JARDIANCE®	148 of 1,166 (12.7%)	0 of 1,166 (0%)	30 of 1,166

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40512403Yamamoto 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.
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.

1 site 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 1 site in Japan.

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 2 inclusion and 1 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 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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 6 Aug 2025). 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 Subjects With Adverse Drug Reactions (ADRs) (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05262764, which also lists 1 linked publication.

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 24 Mar 2026.