Oral Iron Therapy in Chronic Heart Failure Patients

Phase 3

• Conditions: Heart Failure
• Interventions: Dietary Supplement: Ferrous sulfate; Dietary Supplement: Placebo starch

• Registration Number: NCT02698046
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-12-16
• Status Verified: 2016-02
• Study First Submitted QC: 2016-02-28
• Last Update Submitted: 2016-02-28
• Study First Posted: 2016-03-03
• Last Update Posted: 2016-03-03
• Primary Completion: 2016-06
• Study Completion: 2016-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ferrous sulfate	Ferrous sulfate	-
Placebo	Placebo starch	-

Primary Outcome Measures

Name	Time	Method
Biochemical parameter of serum transferrin saturation	4 months

Secondary Outcome Measures

Name	Time	Method
Biochemical parameter of serum ferritin	4 months
Ejection fraction of the left ventricle on doppler echocardiographic study	4 months	Unit of measure %
Blood pressure results during mechanoreflex evaluation	4 months	Unit of measure mmHg
Biochemical parameter of hemoglobin in the hemogram analysis	4 months
Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels	4 months
Heart rate results during mechanoreflex evaluation	4 months	Unit of measure beats per minute
Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing	4 months	Unit of measure mL/kg/min
Volume of oxygen consumed results during mechanoreflex evaluation	4 months	Unit of measure mL/kg/min
Total score of physical, emotional, and overall dimensions domains of the Minnesota Living with Heart Failure Questionnaire	4 months	Score range 0 to 105 points
Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing	4 months	Unit of measure mL/kg/min

Trial Locations

Locations (1)

Division of Cardiology, Department of Internal Medicine; 🇧🇷 Ribeirao Preto, Sao Paulo, Brazil