Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
|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Recruitment Status : Withdrawn (Lack of cooperation among centers, Financial reasons)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
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384657
|"Dr Carol Davila" Teaching Hospital of Nephrology|
|Bucharest, Romania, 010731|
|"Caritas" Teaching Hospital, Cardiology Department|
|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|