NCT04812873

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
465

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 19, 2021

Last Update Submit

March 22, 2021

Conditions

Iron Deficiency Anemia

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Current Anemia treatment

    1 day

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Korean patients with heart failure

You may qualify if:

  • 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 )

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 37309696DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Ferritin, Hb, Iron, TSAT BNP(or NT-proBNP), RDW, platelet, WBC, neutrophil count, lymphocyte count

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • SOOJIN JUN

    JWPharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 24, 2021

Study Start

January 30, 2019

Primary Completion

November 12, 2019

Study Completion

August 31, 2020

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)