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

NCT ID: NCT05262764

Last Updated: 2025-08-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-15

Study Completion Date

2024-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

JARDIANCE®

Intervention Type DRUG

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

Interventions

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JARDIANCE®

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

Intervention Type DRUG

Other Intervention Names

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empagliflozin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 40512403 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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1245-0286

Identifier Type: -

Identifier Source: org_study_id

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