Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ferric Derisomaltose.
- Who it may be relevant to
- Registry conditions: Chronic Heart Failure, Iron Deficiencies. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is: • How many participants are admitted to the hospital or die from a disease in the heart or blood vessels Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works. Participants will: * Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls
Interventions
- Drug Ferric Derisomaltose
100 mg/mL
Primary outcome measures
- Number of cardiovascular deaths and hospitalizations for worsening heart failure [Time frame: From enrollment to the end of follow-up at 52 weeks]
Secondary outcome measures (12)
- Number of hospitalizations for worsening heart failure [Time frame: From enrollment and no longer than end of follow-up at 52 weeks]
- Time to cardiovascular death [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Number of all-cause hospitalizations [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Time to all-cause death [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Time to first hospitalization for worsening heart failure or cardiovascular death [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Number of hospitalizations for cardiovascular, respiratory, or renal disease [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Time to cardiovascular, respiratory, or renal death [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Time to all-cause death or first hospitalization [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Days hospitalized or dead for cardiovascular reasons at week 52 [Time frame: From enrollment to the end of follow-up at 52 weeks]
- Days hospitalized or dead for any reason at week 52 [Time frame: From enrollment to the end of follow-up at 52 weeks]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Both women and men can join
- Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
- Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
- Have low iron levels in the blood
- New York Heart Association (NYHA) Heart Failure Classification II, III or IV
Exclusion criteria
- Planned cardiac surgery or revascularization or cardiac device implantation
- Pregnant or nursing women
- Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
- Treatment with radiotherapy or chemotherapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Private clinic — Pasadena
Identifiers
NCT: NCT06929806 · P-Monofer-CHF-02