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

Sponsor
JW Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT04812873
Collaborator
(none)
465
Enrollment
1
Location
19
Actual Duration (Months)
24.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    465 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean Patients With Heart Failure
    Actual Study Start Date :
    Jan 30, 2019
    Actual Primary Completion Date :
    Nov 12, 2019
    Actual Study Completion Date :
    Aug 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. The Prevalence of Iron Deficiency [1 day]

      serum ferritin < 100 ㎍/L or serum ferritin 100-299 ㎍/L and TSAT* < 20%

    2. The Prevalence of Iron Deficiency Anemia [1 day]

      include Iron Deficiency criteria & Male: Hb < 13 g/dL, Female Hb < 12 g/dL

    Secondary Outcome Measures

    1. Current Anemia treatment [1 day]

      Number of Participants take Anemia Medication

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of

    Sponsors and Collaborators

    • JW Pharmaceutical

    Investigators

    • Study Director: SOOJIN JUN, JWPharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    JW Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT04812873
    Other Study ID Numbers:
    • JWP-FER-401
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Mar 24, 2021
    Last Verified:
    Mar 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure
    Anemia
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of Mar 24, 2021