Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
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.
|Chronic Kidney Disease Chronic Heart Failure Anemia||Drug: iron sucrose||Phase 3|
|Study Design:||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|
- 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 ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: Group I
iv iron sucrose
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.
No Intervention: Group II
Patients will receive conventional treatment of Chronic Heart Failure.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00384657
|Contact: Gabriel Mircescu, Professor||+40 722 firstname.lastname@example.org|
|Contact: Liliana Garneata, MD, PhDemail@example.com|
|"Dr Carol Davila" Teaching Hospital of Nephrology||Recruiting|
|Bucharest, Romania, 010731|
|Contact: Liliana Garneata, Md, PhD +40722619358 firstname.lastname@example.org|
|Sub-Investigator: Ligia Petrescu, MD, PhD|
|Sub-Investigator: Simona Hildegard Stancu, MD, PhD|
|Sub-Investigator: Cristina Stela Capusa, MD, PhD|
|Principal Investigator: Gabriel Mircescu, Professor|
|Sub-Investigator: Liliana Garneata, MD, PhD|
|"Caritas" Teaching Hospital, Cardiology Department||Recruiting|
|Contact: Ondin Zaharia, MD, PhD email@example.com|
|Principal Investigator: Tiberiu Nanea, Professor|
|Sub-Investigator: Ondin Zaharia, MD, PhD|
|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|