Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-24 @ 6:58 PM
NCT ID:
NCT00384657
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00384657
Study Brief:
Protocol Section:
NCT00384657