Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease

• Status: Withdrawn
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Recently, growing body of evidence support the finding that anemia frequently occurs in patients with chronic heart failure (CHF). Chronic kidney disease (CKD), as well, is highly prevalent among heart failure patients, and both anemia and CKD are independently associated with increased mortality. A vicious circle is established with CHF causing both chronic renal insufficiency and anemia, and CKD further aggravating anemia which, in turn, worsens CHF and so on. Treatment of the anemia breaks this circle and improves the quality of life, cardiac and renal functions in patients with severe CHF.

Intravenous iron alone was proved to allow the maintenance of target hematocrit in one-third of chronic renal failure predialysis patients.

Based on these considerations, intravenous iron for anemia in patients with CHF and moderate CKD would represent a reasonable therapeutic approach.

The aim of the trial is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with CHF NYHA III class and concomitant moderate CKD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anemia Working Group Romania
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria:

• persistent severe CHF: functional class NYHA III (marked limitation of physical activity - comfortable at rest, but less than ordinary activity results in shortness of breath and/or fatigue16); left ventricular ejection fraction (echocardiography) less than 40%; functional and systolic dysfunction criteria must be stable at two different examinations one month apart;

• stable stage 3 chronic kidney disease: estimated GFR between 30-59mL/min/1.73m2 (mean value of three measurements within the last 8 weeks, separated from each other by at least one week); stable renal function (at least three different measurements within the past 8 weeks, separated from each other by at least one week; the difference between the highest and the lowest value should be less than 5mL/min/1.73m2)

• mild to moderate anemia: hemoglobin levels < 12g/dL (mean value of three measurements within the last 8 weeks, separated from each other by at least one week) and stable (at least three measurements within the last 8 weeks; the difference between the highest and the lowest value should be less than 1.5g/dL);

• iron deficiency: absolute (serum ferritin < 100ng/mL) or functional (serum ferritin 100-300ng/mL and transferrin saturation < 20%)

Exclusion Criteria:

• evidence of active gastrointestinal or genital tract bleeding

• folate or vitamin B12 deficiency

• hypothyroidism

• hemolytic anemia

• any primary kidney diseases (glomerulonephritis, interstitial nephritis, cystic diseases)

• systemic diseases with renal involvement (lupus erythematosus, vasculitis, amyloidosis)

• renal artery stenosis (>70% lumen reduction)

• diabetic nephropathy

• severe malnutrition (SGA score C or lower)

• active liver diseases

• infectious conditions

• malignancies

• C-reactive protein > 12 mg/L

• severe anemia (< 8.5g/dL)

• blood transfusions in the preceding two months

• iron therapy in the preceding three months

• concomitant erythropoietin therapy

• severe arterial hypertension (systolic BP >190 mm Hg and/or diastolic BP >115 mm Hg)

• recent history (less than 3 months) of acute coronary syndrome

• recent (less than 1 month) PCI

• recent (less than 1 month) CABG surgery

• active myocarditis

• active endocarditis

• more than mild valvar stenosis

• more than moderate valvar (mitral or aortic) regurgitation

• uncontrolled haemodynamically relevant atrial fibrillation/flutter

• hypertrophic cardiomyopathy

• acute and/or chronic pericarditis

• cor pulmonale

• participation in another study