ORION-HF

Overview
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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.

SEEK ID: https://ldh.zks-mhh.imise.uni-leipzig.de/projects/5

Public web page: Not specified

NFDI4Health PALs: No PALs for this Project

Project created: 6th Jun 2025

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : 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
Language of the title/name : English

Acronym(s) of the Project

Acronym : ORION-HF
Language of the acronym : English

Description(s) of the Project

Description : 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.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Iron Deficiency

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Johann
Family name(s)(*) : Bauersachs
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Bauersachs.Johann@mh-hannover.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School, Department of Cardiology and Angiology
Address : Carl-Neuberg-Str.1, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Not specified
Details about the contributing person(s)
Contributor type(*) : Sponsor (primary)
Given name(*) : Christoph
Family name(s)(*) : Schindler
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Schindler.Christoph@mh-hannover.de
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Hannover Medical School, Center for Clinical Studies
Address : Carl-Neuberg-Str.1, 30625 Hannover
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : EudraCT
Identifier(*) : 2021-000130-3

Characteristics of the Project

Is it an interventional or non-interventional Project? : Interventional
Specification of the type of the Project
Interventional Project type : Single group
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Iron deficiency anaemia
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10022972
Primary health condition or disease name(*) : Left heart failure
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10024106
Primary health condition or disease name(*) : Heart failure with preserved ejection fraction
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10076396
Primary health condition or disease name(*) : Heart failure with reduced ejection fraction
Terminology/classification(*) : MedDRA
Code of the health condition or disease : 10078289
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the blood or blood-forming organs and certain disorders involving the immune mechanism (III), Diseases of the circulatory system (IX)
On which diseases or conditions were the data collected? : []
Collects mortality data? : Not specified
Administrative information about the Project
Status of the ethics committee approval : Request for approval submitted, approval granted
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 21 February 2023
End date : 8 January 2025
Mono- or multicentric? : Monocentric
Number of centers : Not specified
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 18
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : 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 *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
Exclusion criteria : 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) 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.
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : Feraccru® 30 mg hard capsules
Type of the intervention : Drug (including placebo)
Additional information about the intervention : n 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.
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Not specified
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Change in haemoglobin level from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Primary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in serum ferritin from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in transferrin saturation from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in soluble transferrin receptor 1 from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in 6 min walking distance from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in Health-related quality of life (HRQoL, measured by KCCQ-12) from baseline to week 16
Description of the outcome measure : 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.
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in serum N-terminal pro brain natriuretic peptide (NT-proBNP) from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of left ventricular ejection fraction
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of left ventricular diameter
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of left ventricular end-diastolic volume index
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of left ventricular wall thickness
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of left atrial volume index
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of global longitudinal strain
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic marker of left ventricular function from baseline to week 16
Description of the outcome measure : measurement of marker of diastolic function (E/e')
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 16
Description of the outcome measure : measurement of right ventricular diameter
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 16
Description of the outcome measure : measurement of tricuspid annular plane systolic excursion
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in echocardiographic markers of right ventricular function from baseline to week 16
Description of the outcome measure : measurement of estimated systolic pulmonary arterial pressure
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Liver: Change in Albumin from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Liver: Change in Alanine transaminase (ALT) from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Liver: Change in Aspartate transaminase (AST) from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Liver: Change in Bilirubin from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Kidney: Change in Creatinine (+Glomerular filtration rate) from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Change in New York Heart Association (NYHA) class from baseline to week 16
Description of the outcome measure : Not specified
Type of the outcome measure : Secondary
Time point(s) of assessment : baseline to week 16
Name of the outcome measure(*) : Incidence of treatment-emergent adverse events (AEs)
Description of the outcome measure : To assess the safety and tolerability of oral ferric maltol in heart failure patients with iron deficiency and anaemia.
Type of the outcome measure : Other
Time point(s) of assessment : up to Week 20
Name of the outcome measure(*) : Incidence of Adverse Events
Description of the outcome measure : Number of drop-outs due to AEs
Type of the outcome measure : Not specified
Time point(s) of assessment : up to Week 20
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : No, there is no plan to make data available
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : false
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : []
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-4
Masking of intervention(s) assignment
Masking implemented? : false
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not specified
Off-label use of a drug product : Not specified

ORION-HF

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