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OpenTrials
Completed

NCT Number: NCT05262764

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, 1416017, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JARDIANCE®

Drug

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

Other names: empagliflozin

Primary outcomes

  1. 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).

Secondary outcomes

  1. Incidence of All-cause Death

    Time frame: Up to 52 weeks

    Incidence of all-cause death.

  2. Incidence of Cardiovascular Death

    Time frame: Up to 52 weeks

    Incidence of cardiovascular death.

  3. Incidence of Hospitalizations for Heart Failure

    Time frame: Up to 52 weeks

    Incidence of hospitalizations for heart failure.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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