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PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Ferric derisomaltose for Heart Failure With Reduced Ejection Fraction

This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as dummy treatment (placebo).

Official registry: https://clinicaltrials.gov/study/NCT05971732 · China-Japan Friendship Hospital · enrollment listed as 146

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 Ferric derisomaltose, or Placebo. The registry lists allocation as randomized. This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency.

They plan to enroll about 146 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Effects of Ferric Derisomaltose Administered Before Hospital Discharge in Stabilised Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life: a Randomised, Parallel-group, Double-blind, Placebo Controlled Trial (COREVIVE-HFrEF)

Interventions: Ferric derisomaltose, Placebo

Primary outcome (registry wording): Change in 6-minute walking distance

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \<50% before randomization
  • Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV
  • Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:
  • Systolic blood pressure≥100mmHg, without symptoms of hypotension;
  • Stop using intravenous diuretics;
  • Neither intravenous inotropic drugs or vasodilators were used (including nitrates)
  • Subject is iron deficient defined as serum ferritin \<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \<20%

Public study contact (from the registry)

Ying Zhou, Dr

+86-13699164283

929352903@qq.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 NCT05971732 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 NCT05971732?

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 NCT05971732?

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