Heart Failure, Left-sidedPhase 4NCT05697211
ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure (ORION-HF)
A Phase 4 study testing Ferric maltol 30 mg (Feraccru®) in people with Heart Failure, Left-sided and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.
Trial summary
This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Left-sided, Anemia, Iron Deficiency
- What is being tested?
- Ferric maltol 30 mg (Feraccru®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 21 Feb 2023to 8 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Men, women*, inter/diverse aged ≥ 18 at day of inclusion
- Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- Patients with chronic heart failure with an Left ventricular ejection fraction (LVEF)<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with a mid-range ejection fraction (HFmrEF)) or patients with chronic heart failure with an EF≥50% (HFpEF) and New York Heart Association functional class II-IV
- 6 min walk distance >50 m
- Mild-to-moderate anaemia and iron -deficiency as defined by a haemoglobin concentration ≥8 g/dl and <12 g/dl in females or ≥9 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-299 µg/l and transferrin saturation <20% at screening
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- *Women without childbearing potential defined as follows:
- females before menarche (if applicable)
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state > 1 year or
- < 50 years and in postmenopausal state > 1 year with serum Follicle stimulating hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening or
- Women of childbearing potential:
- who are practicing sexual abstinence (periodic abstinence and withdrawal are not acceptable) or
- who have sexual relationships with female partners only and/or with sterile male partners or
- who are sexually active with fertile male partner, have a negative pregnancy test during screening and agree to use reliable methods of contraception** from the time of screening until end of the clinical trial.
- The following methods of contraception are acceptable): e.g.
- progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- male or female condom with or without spermicide
- cap, diaphragm or sponge with spermicide
Who cannot join
- Active haematological disorders other than anaemia and/or iron -deficiency
- Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
- Active malignancy or currently receiving chemotherapy or radiotherapy
- Active infectious disease
- Active bleeding
- Severe renal insufficiency (glomerular filtration rate (GFR) < 20ml/min or requiring dialysis)
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- Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
- Ongoing oral or intravenous iron supplementation
- Concomitant erythropoietin medication
- Erythropoiesis stimulating agents (ESA), i.v. iron or blood transfusion administered in last 3 months and oral iron (>100 mg/day) in previous 4 weeks
- Pregnancy or lactation period
- Subject has received any investigational medication or any investigational devices within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/ devices trial, or is scheduled to receive investigational drug/devices during the course of the study
- Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
- Known haemochromatosis or other iron overload syndromes
- Patients with severe, uncorrected valvular heart disease
- Clinical evidence of Acute coronary syndrome (ACS), Transient ischaemic attack (TIA) or stroke within the last 30 days
- Coronary artery bypass graft (CABG), Percutaneous transluminal coronary angioplasty (PTCA), cardiac device implant/resynchronisation therapy or major surgery leading to significant blood loss within last 30 days
- Planned CABG, PTCA, cardiac device implant/resynchronisation therapy or major surgery
- Anaemia due to reasons other than iron deficiency (e.g., haemoglobinopathy). Subjects with Vitamin B12 or folic acid deficiency who in the opinion of the Investigator are stable and asymptomatic will be permitted.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department of Cardiology and Angiology
Hanover, Lower Saxony, 30625
About this study
Official title: A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure
This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.
- Conditions
- Heart Failure, Left-sided, Anemia, Iron Deficiency
- Being tested
- Ferric maltol 30 mg (Feraccru®)
- Keywords
- Iron Deficiency
- Medical subject headings
- Heart Failure, Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric maltol 30 mg (Feraccru®)Drug
In this trial Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects.
| Study group | Role | What they receive |
|---|---|---|
| Feraccru® 30 mg hard capsules | Experimental | Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach Receives: Drug: Ferric maltol 30 mg (Feraccru®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemoglobin level from baseline to week 16
Measured: baseline to week 16
Secondary outcomes (23)
Change in serum ferritin from baseline to week 16
Measured: baseline to week 16
Change in transferrin saturation from baseline to week 16
Measured: baseline to week 16
Change in soluble transferrin receptor 1 from baseline to week 16
Measured: baseline to week 16
Change in 6 min walking distance from baseline to week 16
Measured: baseline to week 16
Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16
KCCQ = Kansas City Cardiomyopathy Questionnaire
The KCCQ 12 is a health-related quality of life questionnaire to measure the disease-specific health status of patients with heart failure. It is a 12 item questionnaire that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge and quality of life. Scores are generated for each domain and scaled from 0 to 100, with 0 denoting the lowest reportable health status and 100 the highest reportable health status.
Measured: baseline to week 16
Change in serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left ventricular ejection fraction
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left ventricular diameter
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left ventricular end-systolic volume index
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left ventricular end-diastolic volume index
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left ventricular wall thickness
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of left atrial volume index
Measured: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
measurement of global longitudinal strain
Measured: baseline to week 16
Change in echocardiographic marker of left ventricular function from baseline to week 16
measurement of marker of diastolic function (E/e')
Measured: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
measurement of right ventricular diameter
Measured: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
measurement of tricuspid annular plane systolic excursion
Measured: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
measurement of estimated systolic pulmonary arterial pressure
Measured: baseline to week 16
Liver: Change in Albumin from baseline to week 16
Measured: baseline to week 16
Liver: Change in Alanine transaminase (ALT) from baseline to week 16
Measured: baseline to week 16
Liver: Change in Aspartate transaminase (AST) from baseline to week 16
Measured: baseline to week 16
Liver: Change in Bilirubin from baseline to week 16
Measured: baseline to week 16
Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16
Measured: baseline to week 16
Change in New York Heart Association (NYHA) class from baseline to week 16
Measured: baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start21 Feb 2023
- Primary completion8 Jan 2025
- Study completion8 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, Left-sidedStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Norgine
- Responsible party
- Sponsor
- Investigators
- Johann Bauersachs, Prof. Dr., Principal investigator, Hannover Medical School, Department of Cardiology and Angiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697211
- Sponsor's protocol ID
- ORION-HF
- Status last verified
- Mar 2025
- First submitted
- 18 Aug 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Explore Safety, Tolerability and Efficacy of ORal IrON Supplementation with Ferric Maltol in Treating Iron Deficiency and Anaemia in Patients with Heart Failure
- ClinicalTrials.gov ID
- NCT05697211
- Acronym / sponsor ID
- ORION-HF
- Conditions
- Heart Failure, Left-sided, Anemia, Iron Deficiency
- Keywords
- Iron Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Norgine
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 8 Jan 2025 (actual)
- Study completion
- 8 Jan 2025 (actual)
- First posted
- 25 Jan 2023 (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.
This is an open-label, single arm, multicenter pilot-study to explore the safety, tolerability and efficacy of oral iron supplementation with ferric maltol in treating iron deficiency and anaemia in patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feraccru® 30 mg hard capsules | Experimental | Drug: Ferric maltol 30 mg (Feraccru®)Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily p.o., morning and evening, on an empty stomach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Men, women*, inter/diverse aged ≥ 18 at day of inclusion
- Signed written informed consent from patient prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- Patients with chronic heart failure with an Left ventricular ejection fraction (LVEF)<50% (Heart failure with reduced ejection fraction (HFrEF), Heart failure with a mid-range ejection fraction (HFmrEF)) or patients with chronic heart failure with an EF≥50% (HFpEF) and New York Heart Association functional class II-IV
- 6 min walk distance >50 m
Key exclusion criteria (19 listed)
- Active haematological disorders other than anaemia and/or iron -deficiency
- Other medical condition that according to the investigator's assessment is causing or contributing to anaemia
- Active malignancy or currently receiving chemotherapy or radiotherapy
- Active infectious disease
- Active bleeding
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 maltol 30 mg (Feraccru®)In this trial Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects. | Drug | Feraccru® 30 mg hard capsules |
Primary outcome
Change in haemoglobin level from baseline to week 16
Time frame: baseline to week 16
23 secondary outcomes
Change in serum ferritin from baseline to week 16
Time frame: baseline to week 16
Change in transferrin saturation from baseline to week 16
Time frame: baseline to week 16
Change in soluble transferrin receptor 1 from baseline to week 16
Time frame: baseline to week 16
Change in 6 min walking distance from baseline to week 16
Time frame: baseline to week 16
Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16
Time frame: baseline to week 16
Change in serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic marker of left ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
Time frame: baseline to week 16
Change in echocardiographic markers of right ventricular function from baseline to week 16
Time frame: baseline to week 16
Liver: Change in Albumin from baseline to week 16
Time frame: baseline to week 16
Liver: Change in Alanine transaminase (ALT) from baseline to week 16
Time frame: baseline to week 16
Liver: Change in Aspartate transaminase (AST) from baseline to week 16
Time frame: baseline to week 16
Liver: Change in Bilirubin from baseline to week 16
Time frame: baseline to week 16
Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16
Time frame: baseline to week 16
Change in New York Heart Association (NYHA) class from baseline to week 16
Time frame: baseline to week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- 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. This study is not recruiting at the moment.
Johann Bauersachs, Prof. Dr. principal investigator
Hannover Medical School, Department of Cardiology and Angiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ferric maltol 30 mg (Feraccru®) in people with Heart Failure, Left-sided and Anemia, Iron Deficiency, run by Hannover Medical School at 1 site in Germany.
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 20 inclusion and 19 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: finished, as of the sponsor's last update on 7 Mar 2025. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in haemoglobin level from baseline to week 16 (time frame: baseline to week 16). 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 7 Mar 2025.