Status:
WITHDRAWN
Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
Lead Sponsor:
Anemia Working Group Romania
Conditions:
Chronic Kidney Disease
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 hear...
Detailed Description
Intravenous iron administration in CHF patients with absolute or functional iron deficiency could correct their anemia, thus improving cardiac function judged by ejection fraction and NYHA functional ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00384657
Start Date
January 1 2008
End Date
December 1 2017
Last Update
December 22 2017
Active Locations (2)
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1
"Dr Carol Davila" Teaching Hospital of Nephrology
Bucharest, Romania, 010731
2
"Caritas" Teaching Hospital, Cardiology Department
Bucharest, Romania