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
Led by China-Japan Friendship Hospital · Updated on 2025-02-19
114
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will address whether intravenous (IV) iron repletion with a more intensive target will provide greater benefits in improving exercise capacity for patients with chronic heart failure and iron deficiency. One group of participants will receive a high-dose IV iron regimen with a more intensive target, and the other group will receive a low-dose IV iron regimen with a less intensive target.
CONDITIONS
Official 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 over 18 years
- Left ventricular ejection fraction less than 50% within 2 years prior to randomization
- New York Heart Association class II to III
- Hospitalization for heart failure within 6 months prior or elevated natriuretic peptides within 3 months
- Stable chronic heart failure on optimal therapy for at least 4 weeks with no recent dose changes in heart failure drugs except diuretics
- Serum ferritin less than 100 ng/mL or ferritin 100-300 ng/mL with transferrin saturation less than 20%
- Able and willing to perform a cardiopulmonary exercise test at randomization
- Able and willing to provide informed consent
You will not qualify if you...
- Hemoglobin less than 9.0 g/dL or greater than 15.0 g/dL
- Renal dialysis or estimated glomerular filtration rate less than 15 ml/min/1.73m2
- Body weight less than 35 kg
- Heart failure caused by valvular or congenital heart diseases
- History or family history of iron overload or hemochromatosis
- Known hypersensitivity to ferric derisomaltose or other IV iron products
- Active infection, bleeding disorders, malignancy, or hemolytic anemia
- Chronic liver disease or elevated liver enzymes more than three times normal, myelodysplastic disorder, HIV/AIDS
- Recent acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months
- Recent or planned cardiac surgery or revascularization within 3 months
- Recent erythropoietin, IV or oral iron therapy, or blood transfusion within 30 days
- Use of immunosuppressive therapy
- Diseases preventing exercise testing such as severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, uncontrolled arrhythmia, or uncontrolled hypertension
- Possible alternative diagnosis for heart failure symptoms like severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease
- Pregnancy or breastfeeding
- Participation in another drug or device intervention study within past 90 days
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
J
Jingyi Ren
CONTACT
L
Lina Su
CONTACT
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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