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

Boehringer Ingelheim1,200 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Heart Failure

Interventions

JARDIANCE®DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Nippon Boehringer Ingelheim Co., Ltd.

Tokyo, Japan

Outcomes

Primary Outcomes

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).

Time frame: Up to 52 weeks

Secondary Outcomes

Incidence of All-cause Death

Incidence of all-cause death.

Time frame: Up to 52 weeks

Incidence of Cardiovascular Death

Incidence of cardiovascular death.

Time frame: Up to 52 weeks

Incidence of Hospitalizations for Heart Failure

Incidence of hospitalizations for heart failure.

Time frame: Up to 52 weeks

Data from ClinicalTrials.gov

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