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Compares treatment options for Heart Failure
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
ClinicalTrials.gov ID: NCT06427343
What this study is testing
What is High-dose ferric derisomaltose?
High-dose ferric derisomaltose is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for heart failure.
Also referred to as More intensive target.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age \>18 years.
- Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).
- New York Heart Association (NYHA) class II \~ III.
- Either hospitalization for HF within 6 months prior to planned randomization or elevated plasma levels of natriuretic peptides within 3 months of...
- people with stable CHF (NYHA II/III functional class) on optimal background therapy (as determined by the investigator) for at least 4 weeks with no...
You likely can't join if
- Hemoglobin \ 15.0 g/dL.
- Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2.
- Body weight \<35 kg.
- Heart failure was secondary to valvular diseases or congenital heart diseases.
- History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.
- Known hypersensitivity to ferric derisomaltose or other IV iron product.
See the full eligibility criteria
- Age \>18 years.
- Left ventricular ejection fraction (LVEF) \<50% within 2 years prior to planned randomization (assessed by echocardiography or MRI).
- New York Heart Association (NYHA) class II \~ III.
- 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...
- people 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...
- Serum ferritin \<100 ng/mL or serum ferritin 100-300 ng/mL and TSAT \<20%.
- Able and willing to perform a CPET at the time of randomization.
- Able and willing to provide informed consent.
- Hemoglobin \ 15.0 g/dL.
- Renal dialysis or MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) \<15 ml/min/1.73m2.
- Body weight \<35 kg.
- Heart failure was secondary to valvular diseases or congenital heart diseases.
- History of acquired iron overload; known hemochromatosis or first relatives with hemochromatosis.
- Known hypersensitivity to ferric derisomaltose or other IV iron product.
- 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...
- 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.
- Acute myocardial infarction, acute coronary syndrome, transient ischemic attack, or stroke within 3 months prior to randomization.
- Revascularization therapy (coronary artery bypass grafting, percutaneous intervention, or major surgery) within 3 months prior to randomization; or planning cardiac surgery or revascularization.
- Already receiving erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days prior to randomization.
- Use of concurrent immunosuppressive therapy
- 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...
- Investigator considers a possible alternative diagnosis to account for the patient's HF symptoms: severe obesity, primary pulmonary hypertension, or chronic obstructive pulmonary disease.
- Pregnancy or breast feeding.
- Participation in another intervention study involving a drug or device within the past 90 days.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.