Comparing low-dose and high-dose intravenous iron therapy for heart failure patients with iron deficiency

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of high-dose versus low-dose intravenous iron therapy on exercise capacity in patients with chronic heart failure and iron deficiency. Participants will be randomly assigned to receive either a high-dose or low-dose regimen of ferric derisomaltose. The primary outcome will be the change in peak oxygen uptake (VO2) over 12 months. The study aims to clarify whether a more intensive iron repletion strategy leads to better functional outcomes compared to a less intensive approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• China-Japan Friendship Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Jingyi Ren
• Email: renjingyi1213@hotmail.com
• Phone: 18600195099

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.