Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
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ClinicalTrials.gov Identifier: NCT00384657 |
Recruitment Status :
Withdrawn
(Lack of cooperation among centers, Financial reasons)
First Posted : October 6, 2006
Last Update Posted : December 22, 2017
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Chronic Heart Failure Anemia | Drug: iron sucrose | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease |
Actual Study Start Date : | January 2008 |
Actual Primary Completion Date : | December 2017 |
Actual Study Completion Date : | December 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Group I
iv iron sucrose
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Drug: iron sucrose
Patients in Group I will receive iv iron sucrose, as described in the study protocol. Patient in Group II will receive conventional treatment for chronic heart failure. Other Names:
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No Intervention: Group II
Patients will receive conventional treatment of Chronic Heart Failure.
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- percentage of patients with increased ejection fraction [ Time Frame: 12 months ]
- the need for blood transfusions during the study period [ Time Frame: 12 months ]
- serum ferritin level [ Time Frame: 12 months ]
- transferrin saturation [ Time Frame: 12 months ]
- radial myocardial velocities [ Time Frame: 12 months ]
- right ventricular function [ Time Frame: 12 months ]
- global diastolic function [ Time Frame: 12 months ]
- left ventricular mass index [ Time Frame: 12 months ]
- major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke) [ Time Frame: 12 months ]
- hospital admissions [ Time Frame: 12 months ]
- death of the patient (all causes deaths, cardiac deaths) [ Time Frame: 12 months ]
- slope of GFR change [ Time Frame: 12 months ]
- "death" of the kidney (initiation of renal replacement therapy) [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384657
Romania | |
"Dr Carol Davila" Teaching Hospital of Nephrology | |
Bucharest, Romania, 010731 | |
"Caritas" Teaching Hospital, Cardiology Department | |
Bucharest, Romania |
Study Director: | Gabriel Mircescu, Professor | Dr Carol Davila Teaching Hospital of Nephrology | |
Principal Investigator: | Tiberiu Nanea, Professor | "Caritas" Teaching Hospital, Bucharest | |
Principal Investigator: | Liliana Garneata, MD, PhD | Dr Carol Davila Teaching Hospital of Nephrology Bucharest |
Responsible Party: | Liliana Garneata, Dr, Anemia Working Group Romania |
ClinicalTrials.gov Identifier: | NCT00384657 |
Other Study ID Numbers: |
AWG_06_01 |
First Posted: | October 6, 2006 Key Record Dates |
Last Update Posted: | December 22, 2017 |
Last Verified: | December 2017 |
chronic heart failure chronic kidney disease anemia intravenous iron |
Kidney Diseases Renal Insufficiency, Chronic Heart Failure Anemia Heart Diseases Cardiovascular Diseases Hematologic Diseases Urologic Diseases |
Renal Insufficiency Iron Ferric Oxide, Saccharated Trace Elements Micronutrients Physiological Effects of Drugs Hematinics |