Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
- Summary
- 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
- Acronym
- ICONIC-HF
- Short title
- Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2025-04-16
- Registry last updated
- 2025-07-23
- Primary completion date
- 2027-12-01
- Start date
- 2025-05-01
- Participants
- 1,900
- Participant count basis
- Estimated
- Planned participants
- 1,900
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Pharmacosmos A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06929806
- ClinicalTrials.gov ID
- NCT06929806
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Outcome assessors
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Timeframe: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for worsening heart failure
Timeframe: From enrollment and no longer than end of follow-up at 52 weeks
Time to cardiovascular death
Timeframe: From enrollment to the end of follow-up at 52 weeks
Number of all-cause hospitalizations
Timeframe: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death
Timeframe: From enrollment to the end of follow-up at 52 weeks
Time to first hospitalization for worsening heart failure or cardiovascular death
Timeframe: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular, respiratory, or renal disease
Timeframe: From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular, respiratory, or renal death
Timeframe: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure
Timeframe: 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
Timeframe: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death or first hospitalization
Timeframe: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for cardiovascular reasons at week 52
Timeframe: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for any reason at week 52
Timeframe: From enrollment to the end of follow-up at 52 weeks
Change in NYHA from baseline to weeks 12, 26 and 52
Timeframe: From enrollment to weeks 12, 26 and 52
All-cause rehospitalizations at 30 and 60 days
Timeframe: From enrollment to 30 and 60 days
Rehospitalizations for worsening heart failure at 30 and 60 days
Timeframe: From enrollment to 30 and 60 days
Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment
Timeframe: From enrollment to the end of follow-up at 52 weeks
Number of urgent and unscheduled outpatient IV diuretic treatment
Timeframe: From enrollment to the end of follow-up at 52 weeks
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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
- 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
- Private clinicPasadena, United StatesRecruiting