Intravenous Iron in Patients with Cardiovascular Disease and Concomitant Iron Deficiency

Phase 1

• Conditions: Patients With Cardiovascular Disease and Concomitant Iron DeficiencyCohort A: Acute myocardial infarction (AMI)Cohort B: Paroxysmal atrial fibrillation or persitent atrial fibrillation (AF)Cohort C: Reduced HF (HF); MedDRA version: 20.0Level: LLTClassification code 10071667Term: Persistent atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: LLTClassification code 10034039Term: Paroxysmal atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10050527Term: Ejection fractionSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2015-005744-34-DE
• Lead Sponsor: niversity Medical Centre Hamburg-Eppendorf

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-28
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

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 < 100 ng/mL or ferritin 100 - 299 ng/mL with TSAT < 20 %)
3. Haemoglobin = 15.5 g/dL
4. Patients aged at least 18 years
5. Provided written informed consent
6. Females/Males who agree to comply with the applicable contraceptive requirements of the pro-tocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified