Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing High-dose ferric derisomaltose for Heart Failure

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.

Official registry: https://clinicaltrials.gov/study/NCT06427343 · China-Japan Friendship Hospital · enrollment listed as 114

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are High-dose ferric derisomaltose, or Low-dose ferric derisomaltose. The registry lists allocation as randomized. 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.

They plan to enroll about 114 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Effects of Low-dose Versus High-dose Intravenous Iron Therapy With Ferric Derisomaltose in Patients With Chronic Heart Failure and Iron Deficiency: a Randomized, Open-label, Blind Endpoint Trial (IRONDOSE)

Interventions: High-dose ferric derisomaltose, Low-dose ferric derisomaltose

Primary outcome (registry wording): Change in peak VO2 (ml/min/kg）

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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
  • 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)
  • 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

Public study contact (from the registry)

Jingyi Ren

18600195099

renjingyi1213@hotmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06427343 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06427343?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06427343?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary