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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 January 2018 |
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Main ID: |
NCT00384657 |
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Date of registration:
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05/10/2006 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous Iron in Patients With Severe Chronic Heart Failure and Chronic Kidney Disease
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Scientific title:
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The Effects of Intravenous Iron Therapy for Anemia Correction in Patients With Severe Chronic Heart Failure and Concomitant Moderate Chronic Kidney Disease |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT00384657 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Romania
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Contacts
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Name:
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Tiberiu Nanea, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Caritas" Teaching Hospital, Bucharest |
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Name:
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Gabriel Mircescu, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dr Carol Davila Teaching Hospital of Nephrology |
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Name:
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Liliana Garneata, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dr Carol Davila Teaching Hospital of Nephrology Bucharest |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease
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Chronic Heart Failure
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Anemia
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Intervention(s)
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Drug: iron sucrose
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Primary Outcome(s)
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percentage of patients with increased ejection fraction
[Time Frame: 12 months]
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Secondary Outcome(s)
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radial myocardial velocities
[Time Frame: 12 months]
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hospital admissions
[Time Frame: 12 months]
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death of the patient (all causes deaths, cardiac deaths)
[Time Frame: 12 months]
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left ventricular mass index
[Time Frame: 12 months]
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serum ferritin level
[Time Frame: 12 months]
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right ventricular function
[Time Frame: 12 months]
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slope of GFR change
[Time Frame: 12 months]
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major cardiovascular events (myocardial infarction, acute pulmonary edema, stroke)
[Time Frame: 12 months]
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the need for blood transfusions during the study period
[Time Frame: 12 months]
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"death" of the kidney (initiation of renal replacement therapy)
[Time Frame: 12 months]
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global diastolic function
[Time Frame: 12 months]
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transferrin saturation
[Time Frame: 12 months]
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Secondary ID(s)
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AWG_06_01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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