Clinical trial NCT05134701: Dapagliflozin Post Marketing Surveillance in HF and CKD
Official title: Dapagliflozin Post-Marketing Surveillance in Heart Failure Patients and Chronic Kidney Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 815
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: On active study drug treatment according to the approved local label.

Brief summary: This is an observational, non-interventional, single-arm multicenter study. The objectives of this study are to assess safety and effectiveness of Forxiga in a real world setting in patients who are prescribed with the study drug according to the newly approved indications in the Republic of Korea

Detailed description: As part of a post-approval commitment, the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea (hereinafter "Korea") requests a study to characterize the safety in patients treated with dapagliflozin by physicians in normal clinical practice settings.

In principle, all patients treated with the product in accordance with the newly updated local prescribing information for HF and/or CKD are eligible for the enrolment in this study. Product prescription and patient enrollment will depend on physicians' medical decision as per routine clinical practice. Patient follow-up will be 12 weeks or about 24 weeks (for long-term surveillance) and patients will be recruited over a period of 4 years after the new HFrEF indication approval by the local health authorities. This is due to the requirements from the local health authorities.

The primary objective of this study is to assess the safety profile of the product in Korean adult patients with heart failure (HF) and/or chronic kidney disease (CKD) in a real world setting under the approved indication(s) in Korea.

The secondary objective of this study is to examine the effectiveness of the product in Korean patients with 1) HF and/or 2) CKD in a real world setting under the approved indication(s) in Korea.

The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with the safety and effectiveness of the product when prescribed under the newly approved indication(s) in Korean patients with 1) HF and/or 2) CKD during the 12 weeks or about 24 weeks of follow-up duration.

Eligibility criteria: Inclusion Criteria:

* Patients aged 19 years old and older
* Patients eligible for the product treatment (i.e. on-label treatment) according to the newly approved HF and/or CKD label in Korea
* Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

* Participation in any interventional trial during the treatment with the product.
* Any off-label indications that are not in accordance with the newly approved label in Korea.
* Any contraindications for the use of the product (as described in the local prescribing information).
* Prior use of product, as per local MFDS guidance.

Primary outcomes:
measure: Incidence (%) of adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs, SADRs
timeFrame: 12weeks or 24weeks
Secondary outcomes:
measure: No worsening in NYHA class from baseline
timeFrame: 12 weeks or 24 weeks
measure: No worsening in UACR category from baseline
timeFrame: 12 weeks or 24 weeks
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Busan
country: Korea, Republic of
facility: Research Site
city: Changwon
country: Korea, Republic of
facility: Research Site
city: Changwon
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon-si
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Iksan
country: Korea, Republic of
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
city: Jeonju
country: Korea, Republic of
facility: Research Site
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Suncheon
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
city: Uijeongbu-si
country: Korea, Republic of
facility: Research Site
Study officials:
References: