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NCT04812873 Clinical Trial

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

Iron Deficiency Anemia Clinical Trial

— HFRegistry  

Official title:
The Prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04812873
Other study ID # JWP-FER-401
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 30, 2019
Est. completion date August 31, 2020

Study information
Verified date March 2021
Source JW Pharmaceutical
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 465
Est. completion date August 31, 2020
Est. primary completion date November 12, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility 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) ? Lung congestion or edema at chest X-ray ? Objective findings of structural or functional cardiac abnormality(more than abnormality level of BNP or NT-proBNP, abnormality of echocardiography ) Exclusion Criteria: - Not applicable

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam-si

Sponsors (1)
Lead Sponsor Collaborator
JW Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Prevalence of Iron Deficiency serum ferritin < 100 ?/L or serum ferritin 100-299 ?/L and TSAT* < 20% 1 day
Primary The Prevalence of Iron Deficiency Anemia include Iron Deficiency criteria & Male: Hb < 13 g/dL, Female Hb < 12 g/dL 1 day
Secondary Current Anemia treatment Number of Participants take Anemia Medication 1 day
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