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A phase III, randomized, open-label, blinded endpoint, comparative trial of ferric derisomaltose versus no intravenous iron in iron-deficient subjects with symptomatic chronic heart failure
EU CTIS ID: 2024-519059-28-00
What this study is testing
To compare the efficacy of ferric derisomaltose to no IV iron on cardiovascular mortality and hospitalizations for worsening heart failure in irondeficient subjects with symptomatic CHF
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Subjects aged ≥18 years at the time of signing the ICF
- 2. LVEF of ≤45 %
- 3. History of heart failure and NYHA class II, III or IV
- 4. Hb ≥9 g/dL and ≤13 g/dL for women; ≥9 g/dL and ≤14 g/dL for men
- 5. TSAT <20 %
- 6. On maximally tolerated guideline-directed medical therapy for heart failure as determined by Investigator
You likely can't join if
- 1. eGFR <15mL/min/1.73m² or on renal replacement therapy
- 10. Received an investigational drug and/or invasive device within 30 days or 5 half-lives, whichever is longer, prior to screening
- 11. Treatment with IV or IM iron within 6 months prior to screening
- 12. Treatment with radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 90 days prior to screening
- 13. Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)
- 14. Any other laboratory abnormality (known B12 or folate deficiency should be corrected but do not exclude the subject), medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements.
See the full eligibility criteria
Who can join
- 1. Subjects aged ≥18 years at the time of signing the ICF
- 2. LVEF of ≤45 %
- 3. History of heart failure and NYHA class II, III or IV
- 4. Hb ≥9 g/dL and ≤13 g/dL for women; ≥9 g/dL and ≤14 g/dL for men
- 5. TSAT <20 %
- 6. On maximally tolerated guideline-directed medical therapy for heart failure as determined by Investigator
- 7. Evidence of being in a higher risk heart failure group: • Currently hospitalized for worsening heart failure (hemodynamically stabilized and expected to survive to discharge). Hospital admission with, or complicated by signs of, worsening heart failure that has resulted in the use of IV diuretics or initiation of or a substantial increase in medication used to treat heart failure (e.g., increase in oral diuretics by 40 mg or more for furosemide or 1 mg or more for bumetanide and/or the addition of a thiazide like diuretic or the addition of a mineralocorticoid receptor antagonist and/or the addition of a sodium-glucose co-transporter 2 inhibitor and/or the addition of sacubitril/valsartan) • Hemodynamically stable CHF subjects identified in outpatient ambulatory services/practice or emergency departments with elevated natriuretic peptides: NT-proBNP >500 pg/mL in sinus rhythm or >1,000 pg/mL in atrial fibrillation (or BNP of >150 pg/mL or 300 pg/mL, respectively)
- 8. At least 1 of the following prognostic enrichment criteria: • Medical history of ischemic heart failure etiology, and/or prior AMI, and/or prior coronary revascularization o eGFR ≤45 mL/min/1.73 m² o TSAT ≤15 % • Anemia as defined by a Hb of ≥9 and <12 g/dL for women and ≥9 and <13 g/dL for men
- 9. Willingness to participate and signing the ICF
What rules you out
- 1. eGFR <15mL/min/1.73m² or on renal replacement therapy
- 10. Received an investigational drug and/or invasive device within 30 days or 5 half-lives, whichever is longer, prior to screening
- 11. Treatment with IV or IM iron within 6 months prior to screening
- 12. Treatment with radiotherapy, chemotherapy or other drugs that suppress the bone marrow, and drugs which have anemia as side effect within 90 days prior to screening
- 13. Any non-viral infection (non-viral infection that has been fully treated before the baseline visit is accepted)
- 14. Any other laboratory abnormality (known B12 or folate deficiency should be corrected but do not exclude the subject), medical condition, or psychiatric disorders which, in the opinion of the Investigator, will put the subject’s disease management at risk or may result in the subject being unable to comply with the trial requirements.
- 2. Chronic defined need for IV iron therapy
- 3. Likely to need or already receiving ESA
- 4. Any of the following cardiovascular comorbidities: • Planned cardiac surgery or revascularization or cardiac device implantation • Within 3 months of screening any of the following: a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident, major cardiovascular surgery or percutaneous coronary intervention, or blood/plasma transfusion • On active cardiac transplant list • Left ventricular assist device implanted
- 5. Any of the following other comorbidities: • Other disease with life expectancy of <2 years • Active clinically relevant bleeding in the Investigator’s opinion • Known or suspected gastrointestinal malignancy
- 6. Pregnant or nursing women. To avoid pregnancy, women of childbearing potential must agree to use contraception as described in Section 16 during the whole trial period and at least 7 days after the last dosing if the subject decides to withdraw
- 7. Previous serious hypersensitivity reactions to any IV iron compounds including ferric derisomaltose
- 8. Iron overload or disturbances in utilization of iron (e.g., haemochromatosis, hemosiderosis)
- 9. ALAT and/or ASAT >3 times upper limit of normal
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Argentina
- India
- Serbia
- United States
- Georgia
- Brazil
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Argentina; India; Serbia; United States; Georgia and 1 more location(s). 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 EU CTIS; the study team decides eligibility.