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

Completed

• Conditions: Heart Failure
• Interventions: Drug: JARDIANCE®

• Registration Number: NCT05262764
• Lead Sponsor: Boehringer Ingelheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-02
• Study Start: 2022-04-15
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-28
• Results First Submitted: 2025-06-27
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-18
• Last Update Submitted: 2025-07-18
• Results First Posted: 2025-08-06
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
JARDIANCE®	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Drug Reactions (ADRs)	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.; 🇯🇵 Tokyo, Japan