Iron deficiency correction in patients with chronic heart failure: a placebo-controlled, double-blind and randomized clinical trial of efficiency

• Grant number: 13/03301-1
• Support Opportunities: Scholarships in Brazil - Doctorate
• Start date: September 01, 2013
• End date: July 31, 2015
• Field of knowledge: Health Sciences - Medicine - Medical Clinics
• Principal Investigator: Marcus Vinicius Simões
• Grantee: Jaqueline Rodrigues de Souza Gentil
• Host Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

This is a placebo-controlled, double-blind and randomized clinical trial with the objective to investigate the effectiveness of the correction of oral iron in patients with chronic stable heart failure with iron deficiency and the central and peripheral mechanisms involved in the improvement of functional capacity after intervention. This trial will include patients with symptomatic stable chronic heart failure (NYHA class II or III), with diagnosis of iron deficiency (ferritin <100 ng / dL or ferritin between 100 - 300 ng / dL with transferrin saturation <20% ) followed in an outpatient clinic (Heart Failure Clinic HCFMRP). The enrolled patients (n = 36) will be randomly selected in the ratio 2:1 to treatment with 60 mg of elemental iron orally (n = 24) in the form of 180 mg ferrous sulfate compound or placebo administration (n = 12) in the form of 180 mg of starch, 3 times daily for 4 months. The primary outcome investigated will be the variation of transferrin saturation, between baseline and after the intervention, considering improves an increase of 10 percentage points from its initial value. Secondary outcomes of the study will be the change in iron stores, RBC indices, neurohumoral activation, left ventricular systolic function, functional capacity, ergoreflex and quality life score. The results will be analyzed with a significance level of 5%. The study was approved by the Research Ethics Committee of the USP-HCFMRP. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

GENTIL, J. R. S.; SCHWARTZMANN, P. V.; SEABRA, L. P.; CARVALHO, E. E. V.; FABRICIO, C. G.; TANAKA, D. M.; BECK-DA-SILVA, L.; SCHMIDT, A.; SIMOES, M. V.. Oral iron administration in chronic heart failure patients with iron deficiency: a randomized, placebo-control and double-blind pilot study. EUROPEAN HEART JOURNAL, v. 38, p. 1-pg., 2017-08-01. (13/03301-1)