TerminatedPhase 3

Iron in Patients With Cardiovascular Disease

Stopped: Due to poor recruitment largely due to the covid pandemic, no safety concerns.

Germany8 participantsStarted 2019-02-28

Plain-language summary

It is now recognized that iron deficiency in cardiovascular disease contributes to impaired clinical outcome.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
✓. Confirmed presence of iron deficiency (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation \< 20 %)
✓. Haemoglobin ≤ 15.5 g/dL
✓. Written informed consent

✕. Evidence of iron overload or disturbances in the utilisation of iron
✕. History of severe asthma, eczema or other atopic allergy
✕. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
✕. Use of renal replacement therapy
✕. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.

Cohort A: Left-ventricular ejection fraction

Timeframe: 16 weeks

Cohort B: Burden of atrial fibrillation

Timeframe: 12 months

Cohort C: Left-ventricular ejection fraction

Timeframe: 16 weeks

NCT IDNCT03991000

SponsorDr. med. Mahir Karakas

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-15

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Cohort A (acute myocardial infarction): Acute Myocardial Infarction within 10 days (randomization/ first iron supplementation/ MRI must be performed within 10 days after AMI), without prior heart failure (defined as any known previous report of LVEF ≤ 45%) Cohort B (atrial fibrillation): Paroxysmal Atrial fibrillation or persistent AF Cohort C (heart failure): Left-ventricular ejection fraction ≤ 45 % (documented within the last 12 months prior to screening), all NYHA classes allowed
✓. Confirmed presence of iron deficiency (ferritin \< 100 ng/mL or ferritin 100 - 299 ng/mL with transferrin saturation \< 20 %)
✓. Haemoglobin ≤ 15.5 g/dL
✓. Written informed consent

✕. Evidence of iron overload or disturbances in the utilisation of iron
✕. History of severe asthma, eczema or other atopic allergy
✕. History of immune or inflammatory conditions (e.g. systemic lupus erythematosus, rheumatoid arthritis)
✕. Use of renal replacement therapy
✕. Treatment with an erythropoietin stimulating agent (ESA), any i.v. iron and/or a blood transfusion in the previous 4 weeks prior to randomisation.