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The effect of ferric citrate on heart failure

Not Applicable
Recruiting
Conditions
Heart failure
Registration Number
JPRN-jRCTs041220137
Lead Sponsor
Hamano Takayuki
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
162
Inclusion Criteria

1.Age 20 years or older
2.Heart failure with left ventricular ejection fraction less than 50%
3.Iron deficiency, defined by ferritin less than 100 ng/mL or ferritin less than 300 ng/mL and transferrin
saturation less than 20%
4. Mild anemia (Hb>=10g/dL and Hb<13g/dL in men, Hb<12g/dL in women
5.Those who can perform cardiopulmonary exercise test
6.Those on the stable dose of medications for heart failure including RAS inhibitors, SGLT2 inhibitors,beta-blockers, or ARNI for more than 2 months
7. Those who consented for participation in this research

Exclusion Criteria

1.Hemoglobin less than 10g/dL, decrease in hemoglobin more than 1g per month
2.History of gastrointestinal bleeding, surgery, or transfusion within 3 months
3.Expecting surgery in next 4 months
4.Pregnant or lactating women and women who intend to be pregnant
5.Those who are already receiving oral or intravenous iron treatment
6.Those who have experienced serious adverse events by oral iron in the past
7.Chemotherapy for malignancy
8.Hematological malignancy including myelodysplastic syndrome
9.Those on dialysis
10. Those on erythropoiesis stimulating agents or hypoxia-inducible factor prolyl hydroxylase inhibitors
11.Those who were considered to be inappropriate to participate in the study by treating physicians

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
% predicted peak VO2 measured by cardiopulmonary exercise testing
Secondary Outcome Measures
NameTimeMethod
KCCQ score, left ventricular ejection fraction, BNP, ferritin, transferrin saturation, Hb, MCV, MCH, MCHC, RDW, hepcidin, BUN, creatinine, proteinuria
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