Actively Recruiting
The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)
Led by China-Japan Friendship Hospital · Updated on 2025-02-19
114
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a higher dose of intravenous (IV) iron repletion improves exercise capacity more than a lower dose in patients with chronic heart failure and iron deficiency. This phase 4 randomized, open-label, blind endpoint study aims to compare the effects of high-dose versus low-dose IV iron therapy on peak oxygen uptake over 12 months. The study addresses the uncertainty around optimal iron repletion targets in this patient group, with previous trials showing varied dosing strategies and outcomes. Participants will be randomly assigned to receive either a high-dose or low-dose IV iron regimen using ferric derisomaltose. After initial treatment, iron levels (serum ferritin and transferrin saturation) will be checked every three months to guide further dosing. The high-dose group will continue dosing until ferritin exceeds 700 ng/mL or transferrin saturation exceeds 40%, while the low-dose group receives iron if ferritin falls below 100 ng/mL or ferritin is 100-300 ng/mL with transferrin saturation below 20%. Infusions are administered over 15 to 30 minutes depending on dose size. Participants will undergo assessments including cardiopulmonary exercise testing at randomization and follow-up visits over one year. Researchers will measure changes in peak oxygen uptake, heart rate, walking distance, muscle and heart iron content by MRI, quality of life, cognitive function, heart function, and hospitalization rates. Safety and efficacy will be monitored throughout, with the study concluding after 52 weeks of follow-up to evaluate the impact of iron dosing on exercise and heart failure outcomes.
CONDITIONS
Brief Title
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Left ventricular ejection fraction (LVEF) below 50% within 2 years prior to randomization
- New York Heart Association (NYHA) class II or III
- Hospitalization for heart failure within 6 months or elevated natriuretic peptides within 3 months prior to randomization
- Stable chronic heart failure on optimal therapy for at least 4 weeks with no recent medication changes except diuretics
- Serum ferritin below 100 ng/mL or ferritin 100-300 ng/mL with transferrin saturation below 20%
- Able and willing to perform cardiopulmonary exercise testing at randomization
- Able and willing to provide informed consent
You will not qualify if you...
- Hemoglobin below 9.0 g/dL or above 15.0 g/dL
- Renal dialysis or estimated glomerular filtration rate below 15 ml/min/1.73m2
- Body weight below 35 kg
- Heart failure caused by valvular or congenital heart diseases
- History of acquired iron overload or hemochromatosis
- Known allergy to ferric derisomaltose or other IV iron products
- Active infection, bleeding disorders, cancer, or hemolytic anemia
- Chronic liver disease or elevated liver enzymes above 3 times normal
- Recent acute heart events or procedures within 3 months
- Recent use of erythropoietin, iron therapy, or blood transfusion within 30 days
- Use of immunosuppressive therapy
- Diseases preventing exercise testing like severe musculoskeletal disease, unstable angina, or uncontrolled arrhythmia
- Possible alternative diagnoses such as severe obesity, pulmonary hypertension, or chronic obstructive pulmonary disease
- Pregnancy or breastfeeding
- Participation in another drug or device study within past 90 days
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either a high-dose or low-dose intravenous ferric derisomaltose regimen to treat iron deficiency in chronic heart failure. Dosing and repeat infusions are based on blood test results measured every three months.
Visits every 3 months for blood tests and iron dosing as needed
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jingyi Ren
L
Lina Su
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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