Effect of Iron on Cardiac Energy Levels in Patients with Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial.

Effect of Iron (III) Isomaltoside 1000 on Cardiac Energetics in Anaemic and Non-anaemic Patients with Symptomatic Chronic Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial - Ferric Iron in Heart Failure (FERRIC-HF) III Trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-004667-13-GB

Enrollment

Registered

2018-03-14

Start date

2018-04-24

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849 MedDRA version: 20.0 Level: PT Classification code 10022970 Term: Iron deficiency System Organ Class: 10027433 - Metabolism and nutrition disorders

Interventions

Trade Name: Iron (III) Isomaltoside 1000 Product Name: Iron (III) Isomaltoside 1000 Pharmaceutical Form: Solution for injection/infusion INN or Proposed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Aged 18 to 89 years • Ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: • Inability to provide written informed consent • Inability to sufficiently understand information pertaining to the conduct of the trial • Contraindications to 31P-MRS (e.g. pacemaker, metal prosthesis, etc) • Ischaemic cardiomyopathy • Folate and vitamin B12 levels below laboratory normal limit. • Use of erythropoietic agent, blood transfusion or immunosuppressive therapy in the preceding 30 days, or ongoing anticipated need for these agents during the study. • Acute or chronic bleeding, infective or inflammatory disorders (Rheumatoid Arthritis, Lupus, HIV/AIDS, malignancy, etc.) • History of iron overload or haemochromatosis in patient or first degree relatives. • Prior intolerance to intravenous iron formulations or any of their excipients • Chronic liver disease and/or aspartate transaminase (AST) >3 times the upper limit of the normal range • Renal dialysis (Haemodialysis or peritoneal dialysis) • Severe asthma or any severe lung disease with FEV1110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias. • Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing. • Pregnant or breast feeding • Contemporaneous enrolment in another clinical trial

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal research question addressed by this trial is to assess the effect of intravenous repletion of iron on the ability of the heart to produce energy in iron deficient heart failure patients.; Secondary Objective: The secondary research questions are the following: 1. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in exercise capacity 2. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in cardiac structure and function 3. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in myocardial iron content 4. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in blood markers of disease and iron status (e.g., iron status, electrolytes, full blood count, metabolic bloods) 5. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in symptoms 6. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in Quality of Life (QoL). ;Primary end point(s): Cardiac Phosphocreatine to ATP ratio (PCr:ATP) measured by 31Phosphorus Cardiac Magnetic Resonance Spectroscopy.;Timepoint(s) of evaluation of this end point: PCr:ATP ratio will be assessed at baseline and at 4 weeks after treatment.	—

Measure

Time frame

Main Objective: The principal research question addressed by this trial is to assess the effect of intravenous repletion of iron on the ability of the heart to produce energy in iron deficient heart failure patients.; Secondary Objective: The secondary research questions are the following: 1. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in exercise capacity 2. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in cardiac structure and function 3. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in myocardial iron content 4. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in blood markers of disease and iron status (e.g., iron status, electrolytes, full blood count, metabolic bloods) 5. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in symptoms 6. The differential impact of iron repletion on anaemic and non-anaemic iron deficient heart failure patients in Quality of Life (QoL). ;Primary end point(s): Cardiac Phosphocreatine to ATP ratio (PCr:ATP) measured by 31Phosphorus Cardiac Magnetic Resonance Spectroscopy.;Timepoint(s) of evaluation of this end point: PCr:ATP ratio will be assessed at baseline and at 4 weeks after treatment.

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Secondary

Measure	Time frame
Secondary end point(s): 1.Change from baseline to week 4 in exercise capacity as assessed by the 6 minute walk distance (6MWD) 2.Change from baseline to week 4 in cardiac structure and function as assessed using magnetic resonance imaging (MRI) and echocardiography 3.Change from baseline to week 4 in myocardial iron content as assessed by T2* value on Cardiac MRI. 4.Change from baseline to week 4 in blood tests (e.g., iron status, electrolytes, full blood count, metabolic bloods) 5.Change from baseline to week 4 in symptoms (as assessed by New York Heart Association [NYHA] class and Visual Analogue Fatigue Scale [VAFS]). 6.Change from baseline to week 4 in Quality of Life (QoL) as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]. 7.Number and incidence of adverse events ;Timepoint(s) of evaluation of this end point: At baseline and at 4 weeks after treatment allocation	—

Measure

Time frame

Secondary end point(s): 1.Change from baseline to week 4 in exercise capacity as assessed by the 6 minute walk distance (6MWD) 2.Change from baseline to week 4 in cardiac structure and function as assessed using magnetic resonance imaging (MRI) and echocardiography 3.Change from baseline to week 4 in myocardial iron content as assessed by T2* value on Cardiac MRI. 4.Change from baseline to week 4 in blood tests (e.g., iron status, electrolytes, full blood count, metabolic bloods) 5.Change from baseline to week 4 in symptoms (as assessed by New York Heart Association [NYHA] class and Visual Analogue Fatigue Scale [VAFS]). 6.Change from baseline to week 4 in Quality of Life (QoL) as assessed by the Kansas City Cardiomyopathy Questionnaire [KCCQ]. 7.Number and incidence of adverse events ;Timepoint(s) of evaluation of this end point: At baseline and at 4 weeks after treatment allocation

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Countries

United Kingdom

Contacts

Public ContactDr Darlington Obinnaya Okonko

King's College London BHF Centre of Research Excellence

obi.okonko@kcl.ac.uk+44(0)20 7848 5017

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026