Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure

NCT05236673 | Completed

• 1 other identifier: 1245-0276
• Study Type: observational
• Target: 610
• Locations: 1 country
• Sites: 21

Brief Summary

The primary objective of this study is to monitor the safety profile of Jardiance® in Korean patient with chronic heart failure (New York Heart Association (NYHA) class II-IV) in a routine clinical setting.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Incidence rates of patients with adverse events

  Adverse events will include: Adverse events, unexpected adverse events, unexpected adverse drug reaction, serious adverse events, serious adverse drug reaction, drug-related adverse events, non-serious adverse drug reaction, adverse event of special interest, adverse events leading to discontinuation.

  up to 24 weeks

Secondary Outcomes (22)

• Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline

  at week 12

• Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline

  at week 24

• Occurrence of cardiovascular death after 12 weeks of treatment

  at week 12

• Occurrence of cardiovascular death after 24 weeks of treatment

  at week 24

• Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments

  at baseline, at week 12

Study Arms (1)

Patients who have started at first time on Jardiance®

Drug: JARDIANCE®

Interventions

JARDIANCE® DRUG

JARDIANCE® film-coated tablets 10mg

Also known as: empagliflozin

Patients who have started at first time on Jardiance®

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.

You may qualify if:

• Patients who have started at first time on Jardiance® in accordance with the approved label in Korea for heart failure (HF)
• Chronic heart failure (New York Heart Association (NYHA) class II-IV)
• Age ≥ 19 years at enrolment
• Patients who have signed on the data release consent form

You may not qualify if:

• Patients with previous exposure to Jardiance®
• Known allergy or hypersensitivity to active ingredients empagliflozin or to any of the excipients
• Patients with type 1 diabetes or with prior history of diabetic ketoacidosis (DKA)
• Patient with renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 20 mL/min/1.73 m²
• Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Patient who are pregnant or are nursing or who plan to become pregnant while in the trial
• Patients for whom empagliflozin is contraindicated according local label of Jardiance®

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (21)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Inje University Busan Paik Hospital

Busan, 47392, South Korea

Location

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

Pusan National University Hospital

Busan, 49241, South Korea

Location

Pusan National University Yangsan Hospital

Busan, 50612, South Korea

Location

Kangwon National University Hospital

Chuncheon-si, Gangwon-do, 24289, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Yeungnam University Medical Center

Daegu, 42415, South Korea

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Dongguk University Medical Center

Goyang-si, Gyeonggi-do, 10326, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Chonnam National University Hospital)

Gwangju, 61469, South Korea

Location

Jeonbuk National University Hospital

Jeonju-si, Jeollabuk-do, 54907, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

VHS Medical Center

Seoul, 05368, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, 06591, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: July 28, 2022
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

KR (21)