Registry Study of ID & IDA in Korean Patients With Heart... | NCT04812873

Studies
Registry Study of ID & IDA in Korean Patients With Heart Failure

NCT04812873

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Mar 24, 2021Actual

Enrollment

465Actual

Phase

Not provided

Conditions

Iron Deficiency Anemia

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2019Actual

Primary Completion Date

Nov 12, 2019Actual

Completion Date

Aug 31, 2020Actual

First Submitted Date

Mar 19, 2021

First Submission Date that Met QC Criteria

Mar 22, 2021

First Posted Date

Mar 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2021

Last Update Posted Date

Mar 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prevalence of Iron Deficiency and Iron Deficiency Anemia in Korean HF patient

Detailed Description

Epidemiological study to assess The prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean patients with heart failure

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

465Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Prevalence of Iron Deficiency	serum ferritin < 100 ㎍/L or serum ferritin 100-299 ㎍/L and TSAT* < 20%	1 day
The Prevalence of Iron Deficiency Anemia	include Iron Deficiency criteria & Male: Hb < 13 g/dL, Female Hb < 12 g/dL	1 day

Secondary Outcomes

Measure	Description	Time Frame
Current Anemia treatment	Number of Participants take Anemia Medication	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

more than 19 years old
Informed Consent Form
Hear Failure criteria as belows
- Heart Failure Sign(more than 1 Sx such as fatigue, dyspnea, ankle swelling)
  - Heart Failure Symptom(more than 1 among Jugular venous pressure (JVP) elevation, pulmonary crackle, peripheral edema) ③ Lung congestion or edema at chest X-ray ④ Objective findings of structural or functional cardiac abnormality(more than abnormality level of BNP or NT-proBNP, abnormality of echocardiography )

Exclusion Criteria:

Not applicable

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Korean patients with heart failure

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
SOOJIN JUN	JWPharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37309696	Derived	Park JJ, Yoon M, Cho HW, Lee SE, Choi JO, Yoo BS, Kang SM, Choi DJ. Iron Deficiency in Korean Patients With Heart Failure. J Korean Med Sci. 2023 Jun 12;38(23):e177. doi: 10.3346/jkms.2023.38.e177.

ID	Term
D000747	Anemia, Hypochromic
D000740	Anemia
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases