NCT06427343 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 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 114 participants in total. It began in 2023-10-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Age \>18 years. 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: 1. Hemoglobin \<9.0 g/dL or Hemoglobin \>15.0 g/dL. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06427343 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06427343 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06427343 currently recruiting?
Yes, NCT06427343 is actively recruiting participants. Contact the research team at renjingyi1213@hotmail.com for enrollment information.
Where is the NCT06427343 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06427343 clinical trial?
NCT06427343 is sponsored by China-Japan Friendship Hospital. The trial plans to enroll 114 participants.
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