Clinical trial NCT05236673: Jardiance® Post Marketing Surveillance (PMS) in Korean Patients With Chronic Heart Failure
Official title: A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Jardiance® (Empagliflozin, 10mg) in Korean Patients With Chronic Heart Failure (NYHA Class II-IV)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-02-11
Enrollment: 610
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with chronic heart failure (New York Heart Association (NYHA) class II-IV) in Korea.

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.


Eligibility criteria: Inclusion criteria:

* 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

Exclusion criteria:

* 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®

Primary outcomes:
measure: Incidence rates of patients with adverse events
timeFrame: up to 24 weeks
Secondary outcomes:
measure: Occurrence of hospitalization for heart failure (first and recurrent) after 12 weeks of treatment from baseline
timeFrame: at week 12
measure: Occurrence of hospitalization for heart failure (first and recurrent) after 24 weeks of treatment from baseline
timeFrame: at week 24
measure: Occurrence of cardiovascular death after 12 weeks of treatment
timeFrame: at week 12
measure: Occurrence of cardiovascular death after 24 weeks of treatment
timeFrame: at week 24
measure: Changes from baseline in New York Heart Association (NYHA) functional class after 12 weeks of treatments
timeFrame: at baseline, at week 12
measure: Changes from baseline in New York Heart Association (NYHA) functional class after 24 weeks of treatments
timeFrame: at baseline, at week 24
measure: Changes in ejection fraction (EF) (if available) at 12 weeks compared to baseline
timeFrame: at baseline, at week 12
measure: Changes in ejection fraction (EF) (if available) at 24 weeks compared to baseline
timeFrame: at baseline, at week 24
measure: Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 12 weeks compared to baseline
timeFrame: at baseline, at week 12
measure: Changes in B-type Natriuretic Peptide (BNP) or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) (if available) at 24 weeks compared to baseline
timeFrame: at baseline, at week 24
measure: Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Changes in glycated hemoglobin (HbA1c) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Changes in Fasting Plasma Glucose (FPG) (if available in Type 2 Diabetes (T2D) patients) after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in estimated Glomerular Filtration Rate (eGFR) (if available) after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in body weight after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in body weight after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 12 weeks of treatment
timeFrame: at baseline, at week 12
measure: Change from baseline in blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP)) after 24 weeks of treatment
timeFrame: at baseline, at week 24
measure: Investigator's overall effectiveness evaluation after 12 weeks of treatment
timeFrame: at week 12
measure: Investigator's overall effectiveness evaluation after 24 weeks of treatment
timeFrame: at week 24
Other outcomes:
Locations:
city: Anyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Hallym University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Chuncheon-si, Gangwon-do
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Dongguk University Medical Center
city: Goyang-si, Gyeonggi-do
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital)
city: Jeonju-si, Jeollabuk-do
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Uijeongbu-si, Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu ST. Mary's Hospital
Study officials:
References: