Chronic Heart FailurePhase 3ICONIC-HFNCT06929806
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
A Phase 3 study testing Ferric Derisomaltose in people with Chronic Heart Failure and Iron Deficiencies, run by Pharmacosmos A/S at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Iron Deficiencies
- What is being tested?
- Ferric Derisomaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,900 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 1 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Private clinic
Pasadena, California, 91105
MD
About this study
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
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
- Conditions
- Chronic Heart Failure, Iron Deficiencies
- Being tested
- Ferric Derisomaltose
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric DerisomaltoseDrug
100 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Ferric Derisomaltose | Experimental | 50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below <25 % Receives: Drug: Ferric Derisomaltose |
| Control | No intervention | 50 % of the subjects will receive no IV iron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Measured: From enrollment to the end of follow-up at 52 weeks
Secondary outcomes (17)
Number of hospitalizations for worsening heart failure
Measured: From enrollment and no longer than end of follow-up at 52 weeks
Time to cardiovascular death
Measured: From enrollment to the end of follow-up at 52 weeks
Number of all-cause hospitalizations
Measured: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death
Measured: From enrollment to the end of follow-up at 52 weeks
Time to first hospitalization for worsening heart failure or cardiovascular death
Measured: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular, respiratory, or renal disease
Measured: From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular, respiratory, or renal death
Measured: From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure
Measured: 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
Measured: From enrollment to the end of follow-up at 52 weeks
Time to all-cause death or first hospitalization
Measured: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for cardiovascular reasons at week 52
Measured: From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for any reason at week 52
Measured: From enrollment to the end of follow-up at 52 weeks
Change in NYHA from baseline to weeks 12, 26 and 52
Measured: From enrollment to weeks 12, 26 and 52
All-cause rehospitalizations at 30 and 60 days
Measured: From enrollment to 30 and 60 days
Rehospitalizations for worsening heart failure at 30 and 60 days
Measured: 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
Measured: From enrollment to the end of follow-up at 52 weeks
Number of urgent and unscheduled outpatient IV diuretic treatment
Measured: From enrollment to the end of follow-up at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start1 May 2025
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pharmacosmos Clinical and non-clinical department, Study director, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06929806
- Sponsor's protocol ID
- P-Monofer-CHF-02
- Acronym
- ICONIC-HF
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06929806
- Acronym / sponsor ID
- ICONIC-HF / P-Monofer-CHF-02
- Conditions
- Chronic Heart Failure, Iron Deficiencies
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,900 participants (estimated)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 16 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferric Derisomaltose | Experimental | Drug: Ferric Derisomaltose50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below <25 % |
| Control | No intervention | –50 % of the subjects will receive no IV iron |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Derisomaltose100 mg/mL | Drug | Ferric Derisomaltose |
Primary outcome
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Time frame: From enrollment to the end of follow-up at 52 weeks
17 secondary outcomes
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
Change in NYHA from baseline to weeks 12, 26 and 52
Time frame: From enrollment to weeks 12, 26 and 52
All-cause rehospitalizations at 30 and 60 days
Time frame: From enrollment to 30 and 60 days
Rehospitalizations for worsening heart failure at 30 and 60 days
Time frame: 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
Time frame: From enrollment to the end of follow-up at 52 weeks
Number of urgent and unscheduled outpatient IV diuretic treatment
Time frame: From enrollment to the end of follow-up at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pharmacosmos Clinical and non-clinical department study director
Pharmacosmos A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferric Derisomaltose in people with Chronic Heart Failure and Iron Deficiencies, run by Pharmacosmos A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pharmacosmos Clinical and non-clinical Department (+45 5948 5959, info@pharmacosmos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cardiovascular deaths and hospitalizations for worsening heart failure (time frame: From enrollment to the end of follow-up at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.