Iron Deficiency AnemiaHFRegistryNCT04812873
Registry Study of ID & IDA in Korean Patients With Heart Failure
An observational study of Iron Deficiency Anemia, run by JW Pharmaceutical at 1 site in South Korea.
Trial summary
The prevalence of Iron Deficiency and Iron Deficiency Anemia in Korean HF patient Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iron Deficiency Anemia
- How many people
- 465 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2019to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Korean patients with heart failure
Who may be able to join
- 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 )
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean Patients With Heart Failure
The prevalence of Iron Deficiency and Iron Deficiency Anemia in Korean HF patient
Read the detailed description
Epidemiological study to assess The prevalence of ID (Iron Deficiency) \& IDA (Iron Deficiency Anemia) in Korean patients with heart failure
- Conditions
- Iron Deficiency Anemia
- Medical subject headings
- Anemia, Iron-Deficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The Prevalence of Iron Deficiency
serum ferritin < 100 ㎍/L or serum ferritin 100-299 ㎍/L and TSAT* < 20%
Measured: 1 day
The Prevalence of Iron Deficiency Anemia
include Iron Deficiency criteria \& Male: Hb < 13 g/dL, Female Hb < 12 g/dL
Measured: 1 day
Secondary outcomes (1)
Current Anemia treatment
Number of Participants take Anemia Medication
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start30 Jan 2019
- Primary completion12 Nov 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- JW Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SOOJIN JUN, Study director, JWPharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812873
- Sponsor's protocol ID
- JWP-FER-401
- Acronym
- HFRegistry
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 24 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37309696
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of ID (Iron Deficiency) & IDA (Iron Deficiency Anemia) in Korean Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT04812873
- Acronym / sponsor ID
- HFRegistry / JWP-FER-401
- Conditions
- Iron Deficiency Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 465 participants (actual)
- Lead sponsor
- JW PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 24 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Korean patients with heart failure
Key inclusion criteria (5 listed)
- more than 19 years old
- Informed Consent Form
- Hear Failure criteria as belows
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Prevalence of Iron Deficiency
Time frame: 1 day
serum ferritin < 100 ㎍/L or serum ferritin 100-299 ㎍/L and TSAT* < 20%
The Prevalence of Iron Deficiency Anemia
Time frame: 1 day
include Iron Deficiency criteria \& Male: Hb < 13 g/dL, Female Hb < 12 g/dL
1 secondary outcome
Current Anemia treatment
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2021.
- Derived from this study: PubMed 37309696Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SOOJIN JUN study director
JWPharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Deficiency Anemia, run by JW Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Prevalence of Iron Deficiency (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04812873, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2021.