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Virkningerne af lav-dosis versus høj-dosis intravenøs jernterapi med ferri-derisomaltose hos patienter med kronisk hjertesvigt og jernmangel (IRONDOSE)

4. november 2026 opdateret af: Jingyi Ren, China-Japan Friendship Hospital

Virkningerne af lav-dosis versus højdosis intravenøs jernterapi med ferri-derisomaltose hos patienter med kronisk hjertesvigt og jernmangel: et randomiseret, åbent, blindt endepunktsforsøg (IRONDOSE)

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Iron deficiency is a common and important comorbidity in heart failure. Randomized controlled trials have consistently demonstrated a beneficial effect of IV iron on exercise capacity and quality of life in iron-deficient patients with HF and reduced ejection fraction. However, these randomized controlled trials exhibit striking heterogeneity in targeting levels for maintenance strategies of IV iron repletion. Some studies (FERRIC-HF, FAIR-HF) withheld intravenous iron in cases of ferritin >800 ng/mL, hemoglobin >16.0 g/dL, or transferrin saturation (TSAT) >50%, while other studies (HEART-FID, IRONMAN) focused on targeting levels that are simply above the definition of iron deficiency. Additionally, the PIVOTAL trial showed that high-dose IV iron decreased recurrent heart failure events in patients undergoing hemodialysis compared to a lower-dose regimen. Whether functional outcomes differ between those on lower versus higher iron repletion targets among patients with heart failure remains unknown. This study will help us address this question.

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

114

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100044
        • Rekruttering
        • China-Japan Friendship Hospital
        • Ledende efterforsker:
          • Jingyi Ren
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Medicin: 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.

Andre navne:
  • Mere intensivt mål
Aktiv komparator: 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.
Medicin: 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.

Andre navne:
  • Mindre intensivt mål

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in peak VO2 (ml/min/kg）
Tidsramme: Baseline to Week 52

Peak VO2 measured by a maximal effort Cardiopulmonary Exercise Test (CPET)
Baseline to Week 52

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Skift på 6 minutters gåafstand (m)
Tidsramme: Baseline til uge 26 og uge 52
Baseline til uge 26 og uge 52
Change in VO2 at ventilatory threshold (ml/min）
Tidsramme: Baseline to Week 52

Measured by CPET
Baseline to Week 52
Change in heart rate at peak exercise (bpm)
Tidsramme: Baseline to Week 52

Measured by CPET
Baseline to Week 52
Change in peak respiratory exchange ratio
Tidsramme: Baseline to Week 52

Measured by CPET
Baseline to Week 52
Change in myocardial iron content by cardiac magnetic resonance imaging T2 star
Tidsramme: Baseline to Week 52

Measured by cardiac magnetic resonance imaging
Baseline to Week 52
Change in skeletal muscle iron content by magnetic resonance imaging T2 star
Tidsramme: Baseline to Week 52

Measured by skeletal muscle magnetic resonance imaging
Baseline to Week 52
Change in the clinical summary score by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Tidsramme: Baseline to Week 52

The KCCQ is a validated instrument for self-assessment of quality of life and health status in heart failure patients. The clinical summary score, which is derived from the physical limitations and heart failure symptoms domains of the KCCQ is a valid measure for assessing the patient's health aspects that may be influenced by CV medications. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Baseline to Week 52
Change in the EQ-5D-5L questionnaire indexed value
Tidsramme: Baseline to Week 52

EQ-5D-5L: European Quality of Life-5 Dimensions-5 Levels The EQ 5D questionnaire consists of a health descriptive system for participants to self-classify and rate their health status on the day of administration. The descriptive system includes 5 items/dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, which are coded from 1 (best state) to 5 (worst state).
Baseline to Week 52
Change in cognitive function score by Mini-Mental State Examination (MMSE)
Tidsramme: Baseline to Week 52

The MMSE is a cognitive test. The score is ranged from 0-30 (units of a scale). 30 points is the better outcome. The investigators will assess the change in the score.
Baseline to Week 52
Change in concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP, pg/mL)
Tidsramme: Baseline to Week 52

Tested in blood samples
Baseline to Week 52
Change in left ventricular ejection fraction (LVEF, %)
Tidsramme: Baseline to Week 52

Assessed by echocardiography
Baseline to Week 52
Change in left ventricular global longitudinal stress (LVGLS, %)
Tidsramme: Baseline to Week 52

Assessed by echocardiography
Baseline to Week 52
Mortality and heart failure-related hospitalization rates
Tidsramme: Up to 52 weeks

Effects on mortality and HF-related hospitalization rates in patients with heart failure.
Up to 52 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

China-Japan Friendship Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. oktober 2023

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. august 2027

Datoer for studieregistrering

Først indsendt

19. maj 2024

Først indsendt, der opfyldte QC-kriterier

19. maj 2024

Først opslået (Faktiske)

23. maj 2024

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023-ZF-62

Plan for individuelle deltagerdata (IPD)

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