Intravenous Iron in Patients with Cardiovascular Disease and Concomitant Iron Deficiency

Randomized, Double-Blinded, Controlled Trial of Intravenous Iron in Patients With Cardiovascular Disease and Concomitant Iron Deficiency

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005744-34-DE

Enrollment

240

Registered

2018-09-28

Start date

2019-01-03

Completion date

Unknown

Last updated

2022-01-04

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

Conditions

Patients With Cardiovascular Disease and Concomitant Iron Deficiency Cohort A: Acute myocardial infarction (AMI) Cohort B: Paroxysmal atrial fibrillation or persitent atrial fibrillation (AF) Cohort C: Reduced HF (HF) MedDRA version: 20.0 Level: LLT Classification code 10071667 Term: Persistent atrial fibrillation System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: LLT Classification code 10034039 Term: Paroxysmal atrial fibrillation System Organ Class: 10007541 - Car

Interventions

Trade Name: Ferinject Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: FERRIC CARBOXYMALTOSE CAS Number: 9007-72-1 Concentration unit: mg/ml milligram(s)/millilitre Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Cohort A (AMI): Acute Myocardial Infarction within 10 days (randomization/ first iron supple-mentation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF = 45%) Cohort B (AF): Paroxysmal Atrial fibrillation or persistent AF Cohort C (HF): LVEF = 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed 2. Confirmed presence of ID (ferritin =65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

Exclusion criteria: 1. Evidence of iron overload or disturbances in the utilisation of iron 2. History of severe asthma, eczema or other atopic allergy 3. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis) 4. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 6 weeks prior to randomisation 5. Oral iron therapy at doses > 100 mg/day at randomisation 6. Current use of renal replacement therapy 7. Patient at an immediate need of transfusion (hemoglobin below 7.5 g/dL or at the discretion of the investigator)

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the iCHF-2 trial is to show that treatment of patients with cardiovascular disease and concomitant iron deficiency (ID) with i.v. iron (Ferric Carboxymaltose, FCM) versus control (i.v. NaCl) can improve functional status.;Secondary Objective: not applicable;Primary end point(s): Cohort A (AMI): Change in left-ventricular ejection fraction (LVEF) as determined by cardiac-MRI. Cohort B (AF): Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder. Cohort C (HF): Change in LVEF as determined by cardiac-MRI.;Timepoint(s) of evaluation of this end point: Cohort A (AMI): Change from baseline to week 16 Cohort B (AF): Delta between treatment groups from day 90 to 365 Cohort C (HF): Change from baseline to week 16	—

Measure

Time frame

Main Objective: The primary objective of the iCHF-2 trial is to show that treatment of patients with cardiovascular disease and concomitant iron deficiency (ID) with i.v. iron (Ferric Carboxymaltose, FCM) versus control (i.v. NaCl) can improve functional status.;Secondary Objective: not applicable;Primary end point(s): Cohort A (AMI): Change in left-ventricular ejection fraction (LVEF) as determined by cardiac-MRI. Cohort B (AF): Delta between treatment groups in burden of atrial fibrillation from day 90 to 365 as assessed by a routinely implanted event recorder. Cohort C (HF): Change in LVEF as determined by cardiac-MRI.;Timepoint(s) of evaluation of this end point: Cohort A (AMI): Change from baseline to week 16 Cohort B (AF): Delta between treatment groups from day 90 to 365 Cohort C (HF): Change from baseline to week 16

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Secondary

Measure	Time frame
Secondary end point(s): Cohort-specific secondary endpoints: Cohort A: Change in myocardial salvage, extent of myocardial scar, and area at risk as determined by cardiac MRI Cohort B: Burden of AF, Arrhythmic burden other than AF Cohort C: Change in myocardial salvage, extent of myocardial scar, and area at risk as determined by cardiac MRI. General secondary endpoints (stratified for each cohort): 1. Change in ventricular and atrial diameters, and change of mass index from baseline to follow-up cardiac MRI (only cohorts A and C; see MRI protocol for further read-outs). 2. Change of glomerular filtration rate (as determined by Cystatin C-based calculation) 3. Change of NYHA class 4. Change of distance walked at 6-minute walking test 5. Change of cardiometabolic and transcriptomic biomarkers (troponin T, NT-proBNP) 6. Change of QoL questionnaire (EQ-5D), PGA (patients’ global assessment) questionnaire, questionnaire for sleep quality (Pittsburgh Sleep Quality Index; PSQI), questionnaire for cognitive impairment (Mini mental state exam; MMSE), and questionnaire for depression (Becks depression inventory; BDI). 7. Percentage of patients meeting key safety endpoints defined as time to death, hospitalization for worsening heart failure, myocardial infarction, unscheduled coronary revascularisation, atrial fibrillation (only cohort A and cohort C), ventricular fibrillation, cardiac arrest, stent thrombosis, stroke, cardiac death, or death.;Timepoint(s) of evaluation of this end point: Cohort-specific secondary endpoints: Cohort A: Change from baseline to week 16 Cohort B: Burden of AF between day 90 and 365, day 90 and 730, day 90 and day 1095 (or maximum day of event recording) Arrhythmic burden other than AF between day 90 and days 365/ 730/ 1095 (or maximum day of event recording) Cohort C: Change from baseline to week 16 General secondary endpoints (stratified for each cohort): 1. Change from baseline to follow-up cardiac MRI (only cohorts A and C) 2. , 3., 4., 6	—

Measure

Time frame

Secondary end point(s): Cohort-specific secondary endpoints: Cohort A: Change in myocardial salvage, extent of myocardial scar, and area at risk as determined by cardiac MRI Cohort B: Burden of AF, Arrhythmic burden other than AF Cohort C: Change in myocardial salvage, extent of myocardial scar, and area at risk as determined by cardiac MRI. General secondary endpoints (stratified for each cohort): 1. Change in ventricular and atrial diameters, and change of mass index from baseline to follow-up cardiac MRI (only cohorts A and C; see MRI protocol for further read-outs). 2. Change of glomerular filtration rate (as determined by Cystatin C-based calculation) 3. Change of NYHA class 4. Change of distance walked at 6-minute walking test 5. Change of cardiometabolic and transcriptomic biomarkers (troponin T, NT-proBNP) 6. Change of QoL questionnaire (EQ-5D), PGA (patients’ global assessment) questionnaire, questionnaire for sleep quality (Pittsburgh Sleep Quality Index; PSQI), questionnaire for cognitive impairment (Mini mental state exam; MMSE), and questionnaire for depression (Becks depression inventory; BDI). 7. Percentage of patients meeting key safety endpoints defined as time to death, hospitalization for worsening heart failure, myocardial infarction, unscheduled coronary revascularisation, atrial fibrillation (only cohort A and cohort C), ventricular fibrillation, cardiac arrest, stent thrombosis, stroke, cardiac death, or death.;Timepoint(s) of evaluation of this end point: Cohort-specific secondary endpoints: Cohort A: Change from baseline to week 16 Cohort B: Burden of AF between day 90 and 365, day 90 and 730, day 90 and day 1095 (or maximum day of event recording) Arrhythmic burden other than AF between day 90 and days 365/ 730/ 1095 (or maximum day of event recording) Cohort C: Change from baseline to week 16 General secondary endpoints (stratified for each cohort): 1. Change from baseline to follow-up cardiac MRI (only cohorts A and C) 2. , 3., 4., 6

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Countries

Germany

Contacts

Public ContactMahir Karakas

University Medical Centre Hamburg-Eppendorf

m.karakas@uke.de004940741057975

Outcome results

None listed

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