The effect of ferric citrate on heart failure

JRCT ID: jRCTs041220137

Registered date:08/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Heart failure
• Date of first enrollment: 24/10/2023
• Target sample size: 162
• Study type: Interventional

Intervention(s)

Intervention group: ferric citrate 250mg 2 tablets orally every day for 16 weeks
Control group: No treatment. If hemoglobin is less than 10g/dL, oral iron supplementation other than ferric citrate. Iron supplementation will be stopped when hemoglobin levels reach 10.5g/L

Outcome(s)

• Primary Outcome: % predicted peak VO2 measured by cardiopulmonary exercise testing
• Secondary Outcome: KCCQ score, left ventricular ejection fraction, BNP, ferritin, transferrin saturation, Hb, MCV, MCH, MCHC, RDW, hepcidin, BUN, creatinine, proteinuria

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hamano Takayuki