The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
NCT ID: NCT06427343
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
114 participants
INTERVENTIONAL
2023-10-01
2026-12-21
Brief Summary
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Detailed Description
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This is an investigator-initiated, prospective, randomized, open-label blind endpoint study to assess the effects of high-dose IV iron repletion compared to a low-dose IV iron repletion on 12-month change in peak oxygen uptake (VO2) for patients with chronic heart failure and concomitant iron deficiency.
Patients with chronic heart failure and iron deficiency will be enrolled and randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during the follow-up period. In the high dose group, iron dosing will repeat as long as the serum ferritin was not \>700ng/mL, or if TSAT was not \>40%. Patients in the low dose group will receive repeat iron dosing if ferritin \<100 ng/mL, or if ferritin 100-300 ng/mL and TSAT \<20%, in line with criteria for iron deficiency in current guidelines.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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High dose
Participants randomized to this arm will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up.
Iron to be administered as ferric derisomaltose. Ferric derisomaltose will be administered according to the dosing schedule determined by the patient's body weight and hemoglobin value.
Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses \>1000mg.
High-dose ferric derisomaltose
After baseline assessment, participants will be randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during follow-up.
In the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up.
Low dose
Participants randomized to this arm will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \<20% during follow-up.
Iron to be administered as ferric derisomaltose in analogy to high-dose arm.
Low-dose ferric derisomaltose
In the low-dose group, participants will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \>20% during follow-up.
Interventions
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High-dose ferric derisomaltose
After baseline assessment, participants will be randomized in a 1:1 ratio to receive a high-dose IV iron regimen and a low-dose IV iron regimen. After the initial iron repletion, ferritin concentration and TSAT were measured every three months and the results used to determine the dose of ferric derisomaltose during follow-up.
In the high-dose group, participants will receive repeat iron dosing as long as the serum ferritin was not \>700 ng/mL, or if TSAT was not \>40% during follow-up.
Low-dose ferric derisomaltose
In the low-dose group, participants will receive repeat iron dosing if ferritin \<100 ng/mL or if ferritin 100-300 ng/mL and TSAT \>20% during follow-up.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).
3. New York Heart Association (NYHA) class II \~ III.
4. Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of randomization. a. For patients in sinus rhythm: NT- proBNP \>300 pg/mL or BNP \>100 pg/mL. b. For patients in atrial fibrillation: NT-proBNP \>600 pg/mL or BNP \>200 pg/mL.
5. Subjects with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no dose changes of heart failure drugs during the last 2 weeks (with the exception of diuretics).
6. Serum ferritin \<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \<20%.
7. Able and willing to perform a CPET at the time of randomization.
8. Able and willing to provide informed consent.
Exclusion Criteria
2. Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2.
3. Body weight \<35 kg.
4. Heart failure was secondary to valvular diseases or congenital heart diseases.
5. History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.
6. Known hypersensitivity to ferric derisomaltose or other IV iron product.
7. Known active infection (defined as currently treated with oral or intravenous antibiotics), bleeding (gastrointestinal hemorrhagia, menorrhagia, history of peptic ulcer with no evidence of healing or inflammatory bowel disease), malignancy, and hemolytic anemia.
8. History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) \>3 times the upper limit of the normal range; myelodysplastic disorder; and known HIV/AIDS disease.
9. Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.
10. Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.
11. Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.
12. Use of concurrent immunosuppressive therapy
13. Any of the following diseases that hinders exercise testing: severe musculoskeletal disease, unstable angina, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled slow or rapid arrhythmia (mean ventricular rate \>100 beats/min at rest), or uncontrolled hypertension with blood pressure \>160/100 mm Hg.
14. Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.
15. Pregnancy or breast feeding.
16. Participation in another intervention study involving a drug or device within the past 90 days.
18 Years
ALL
No
Sponsors
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China-Japan Friendship Hospital
OTHER
Responsible Party
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Jingyi Ren
Professor of medicine(Cardiology), Deputy Director of the Cardiology Department and Director of the Heart Failure Center
Locations
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China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-ZF-62
Identifier Type: -
Identifier Source: org_study_id
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