This study is design to evaluate the effectiveness of oral iron therapy in patients with heart failure and identify the central and peripheral mechanisms involved in the improvement of functional capacity after intervention. The investigation includes subjective and objective measures on exercise performance and heart function after intervention, and the tolerability of oral iron treatment.
This is a placebo-controlled, double-blind and randomized clinical trial that will include patients with symptomatic stable chronic heart failure (New York Heart Association Functional Class II or III), with diagnosis of iron deficiency (ferritin \<100 ng / dL or ferritin between 100 - 300 ng / dL and transferrin saturation \<20%) followed in an outpatient clinic. The enrolled patients (n = 36) will be randomly allocated in the ratio 2:1 to treatment with 60 mg of elemental iron orally (n = 24) or placebo administration (n = 12), 3 times daily for 4 months. The primary outcome investigated will be an increase of the transferrin saturation ≥ 10 percentage points between baseline and after the intervention. Secondary outcomes of the study will be the change in iron stores, red blood cell indices, neurohumoral activation, left ventricular systolic function, functional capacity, mechanoreflex activity, and quality life score.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
36
200mg of ferrous sulfate three times a day for 4 months
200mg of placebo starch three times a day for 4 months
Division of Cardiology, Department of Internal Medicine
Ribeirão Preto, São Paulo, Brazil
RECRUITINGBiochemical parameter of serum transferrin saturation
Time frame: 4 months
Biochemical parameter of hemoglobin in the hemogram analysis
Time frame: 4 months
Biochemical parameter of serum ferritin
Time frame: 4 months
Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing
Unit of measure mL/kg/min
Time frame: 4 months
Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing
Unit of measure mL/kg/min
Time frame: 4 months
Ejection fraction of the left ventricle on doppler echocardiographic study
Unit of measure %
Time frame: 4 months
Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels
Time frame: 4 months
Blood pressure results during mechanoreflex evaluation
Unit of measure mmHg
Time frame: 4 months
Heart rate results during mechanoreflex evaluation
Unit of measure beats per minute
Time frame: 4 months
Volume of oxygen consumed results during mechanoreflex evaluation
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Unit of measure mL/kg/min
Time frame: 4 months
Total score of physical, emotional, and overall dimensions domains of the Minnesota Living with Heart Failure Questionnaire
Score range 0 to 105 points
Time frame: 4 months