Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384657
Status:
WITHDRAWN
Last Update Posted:
2017-12-22
First Post:
2006-10-05
Brief Title:
Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
Sponsor:
Anemia Working Group Romania
Organization:
Anemia Working Group Romania
Study Overview
Official Title:
The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease
Status:
WITHDRAWN
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of cooperation among centers Financial reasons
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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 class If true enhancement of cardiac output will increase oxygen delivery to tissues including renal cortex This might improve the renal functions and slow the rate of progression of CKD reflected by the slope of decline in glomerular filtration rate GFR
Since erythropoietin synthesis is located in peritubular fibroblasts from outer renal cortex which is the most affected area during chronic hypoxia increasing renal blood flow after anemia correction is expected to restore optimal erythropoietin production and normalize plasma Epo levels
The primary objective is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with chronic heart failure NYHA III class and concomitant moderate chronic kidney disease
The secondary objectives are to determine if the correction of anemia in these patients affects the cardiac function the rate of progression of CKD and the plasma erythropoietin levels
The study will be conducted in accordance with the Declaration from Helsinki and Tokyo with the amendments from Venice 1983 after the approval by the local ethics committee
The total observation period will be of 28 weeks with a pre-study phase selection randomization of subjects 4 weeksThe study period will last 24 weeks with a possible extension to 48 weeks depending on the results of this first phase
200 anemic patients with chronic heart failure class NYHA III and concomitant stage 3 chronic kidney disease will be enrolled after obtaining their written informed consent
All patients will be evaluated for the inclusion and exclusion criteria at enrollment and at each visit during the pre-study phase Only patients fulfilling all the requested criteria at all evaluation moments will be enrolled The enrolled subjects will be centrally randomly assigned in a 11 ratio into two study groups
Group I treatment group Subjects assigned to this group will receive intravenous iron ferric sucrose product Venofer 2 5mLampoule in a starting dose of 200mg 2 ampoules diluted in 150mL 09 NaCl solution over 60 minutes once a week for the first four administrations and then every other week until hemoglobin levels reach 12gdL Then iron dose will be adjusted to 1 ampoule at 2-4 weeks interval as needed to maintain these levels with serum ferritin 500ngmL
Iron administration will be discontinued if serum ferritin will exceed 500ngmL and will be restarted with a reduced dosage 1 ampoule at every 2-4 weeks once serum ferritin decrease below this value
Conventional treatment for CHF will be continued as needed Group II control group Subjects assigned to this group will continue their conventional treatment for CHF as needed without iron supplementation
No other anti-anemic medication will be administered in either group during the study period
Subjects visits will take place at two weeks intervals in the first 12 weeks of the study phase and at 4 weeks apart thereafter At each visit will be recorded according to the schedule data concerning physical examination including signs of CHF hematological and iron status renal function concomitant medication and adverse events
Parameters recorded at the time of first iron administration will serve as baseline determination
The completion of the study will be declared when 200 subjects will complete the whole observation period according to the above protocol
Since erythropoietin synthesis is located in peritubular fibroblasts from outer renal cortex which is the most affected area during chronic hypoxia increasing renal blood flow after anemia correction is expected to restore optimal erythropoietin production and normalize plasma Epo levels
The primary objective is to assess the efficiency of intravenous iron therapy in the management of mild to moderate anemia associated with chronic heart failure NYHA III class and concomitant moderate chronic kidney disease
The secondary objectives are to determine if the correction of anemia in these patients affects the cardiac function the rate of progression of CKD and the plasma erythropoietin levels
The study will be conducted in accordance with the Declaration from Helsinki and Tokyo with the amendments from Venice 1983 after the approval by the local ethics committee
The total observation period will be of 28 weeks with a pre-study phase selection randomization of subjects 4 weeksThe study period will last 24 weeks with a possible extension to 48 weeks depending on the results of this first phase
200 anemic patients with chronic heart failure class NYHA III and concomitant stage 3 chronic kidney disease will be enrolled after obtaining their written informed consent
All patients will be evaluated for the inclusion and exclusion criteria at enrollment and at each visit during the pre-study phase Only patients fulfilling all the requested criteria at all evaluation moments will be enrolled The enrolled subjects will be centrally randomly assigned in a 11 ratio into two study groups
Group I treatment group Subjects assigned to this group will receive intravenous iron ferric sucrose product Venofer 2 5mLampoule in a starting dose of 200mg 2 ampoules diluted in 150mL 09 NaCl solution over 60 minutes once a week for the first four administrations and then every other week until hemoglobin levels reach 12gdL Then iron dose will be adjusted to 1 ampoule at 2-4 weeks interval as needed to maintain these levels with serum ferritin 500ngmL
Iron administration will be discontinued if serum ferritin will exceed 500ngmL and will be restarted with a reduced dosage 1 ampoule at every 2-4 weeks once serum ferritin decrease below this value
Conventional treatment for CHF will be continued as needed Group II control group Subjects assigned to this group will continue their conventional treatment for CHF as needed without iron supplementation
No other anti-anemic medication will be administered in either group during the study period
Subjects visits will take place at two weeks intervals in the first 12 weeks of the study phase and at 4 weeks apart thereafter At each visit will be recorded according to the schedule data concerning physical examination including signs of CHF hematological and iron status renal function concomitant medication and adverse events
Parameters recorded at the time of first iron administration will serve as baseline determination
The completion of the study will be declared when 200 subjects will complete the whole observation period according to the above protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None