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Oral Iron Therapy in Chronic Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT02698046
Recruitment Status : Unknown
Verified February 2016 by Jaqueline Rodrigues de Souza Gentil, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Jaqueline Rodrigues de Souza Gentil, University of Sao Paulo

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Dietary Supplement: Ferrous sulfate Dietary Supplement: Placebo starch Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oral Iron Therapy in Chronic Heart Failure Patients: a Randomized, Placebo-controlled and Double-blind Clinical Trial (Pilot Study) of Efficiency
Study Start Date : August 2015
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ferrous sulfate Dietary Supplement: Ferrous sulfate
200mg of ferrous sulfate three times a day for 4 months
Placebo Comparator: Placebo Dietary Supplement: Placebo starch
200mg of placebo starch three times a day for 4 months


Outcome Measures
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Primary Outcome Measures :
  1. Biochemical parameter of serum transferrin saturation [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Biochemical parameter of hemoglobin in the hemogram analysis [ Time Frame: 4 months ]
  2. Biochemical parameter of serum ferritin [ Time Frame: 4 months ]
  3. Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing [ Time Frame: 4 months ]
    Unit of measure mL/kg/min

  4. Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing [ Time Frame: 4 months ]
    Unit of measure mL/kg/min

  5. Ejection fraction of the left ventricle on doppler echocardiographic study [ Time Frame: 4 months ]
    Unit of measure %

  6. Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels [ Time Frame: 4 months ]
  7. Blood pressure results during mechanoreflex evaluation [ Time Frame: 4 months ]
    Unit of measure mmHg

  8. Heart rate results during mechanoreflex evaluation [ Time Frame: 4 months ]
    Unit of measure beats per minute

  9. Volume of oxygen consumed results during mechanoreflex evaluation [ Time Frame: 4 months ]
    Unit of measure mL/kg/min

  10. Total score of physical, emotional, and overall dimensions domains of the Minnesota Living with Heart Failure Questionnaire [ Time Frame: 4 months ]
    Score range 0 to 105 points


Other Outcome Measures:
  1. Biochemical parameter of serum urea [ Time Frame: 4 months ]
    Unit of measure mg/dL

  2. Biochemical parameter of serum creatinine [ Time Frame: 4 months ]
    Unit of measure mg/dL

  3. Biochemical parameter of serum sodium [ Time Frame: 4 months ]
    Unit of measure mg/dL

  4. Biochemical parameter of serum potassium [ Time Frame: 4 months ]
    Unit of measure mg/dL


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Both gender patients aged over 18 years;
  • Diagnosis of chronic heart failure (identified by the use of Framingham criteria) for ≥ 6 months;
  • New York Heart Association functional class II and III;
  • Left ventricular ejection fraction ≤ 45%
  • Regular attendance in an outpatient Heart Failure Clinic;
  • Adequate therapeutic drug for heart failure syndrome based on beta-adrenergic blocker, angiotensin converting enzyme inhibitor or angiotensin receptor blocker, and mineralocorticoid receptor blocker;
  • Evidence of iron deficiency in biochemical analyses: ferritin values < 100 ng/dL or between 100 ng/dL and 300 ng/dL, with transferrin saturation < 20%;
  • Hemoglobin value between 9,0 - 16 g/dL;
  • Provide written informed consent.

Exclusion criteria

  • Recent device implant (in the last 3 months) or perspective of device implantation (conventional or multisite pacing) in the next 6 months;
  • Known active infection, inflammatory disease or C-reactive protein > 20 mg/dL
  • Immunosuppressive therapy;
  • In use of erythropoietin and/or current treatment with oral or intravenous iron;
  • Clinically bleeding or blood transfusion in previous 3 months;
  • Renal failure on dialysis;
  • Hemoglobinopathies, hemochromatosis or active malignancy;
  • Unstable angina pectoris or clinically significant uncorrected valvular disease, except mitral and tricuspid regurgitation secondary to ventricular dilatation;
  • Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack within the last 3 months;
  • Uncontrolled arterial hypertension;
  • Evidence of comorbidity that features active systemic disease, i.e. liver disease, collagen disease and untreated hyperthyroidism or hypothyroidism;
  • Pregnant or lactating women;
  • Anaemia due to reasons other than iron deficiency (i.e. vitamin B12 deficiency);
  • Recent admission for decompensated heart failure (last 3 months).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698046


Contacts
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Contact: Jaqueline RS Gentil, Master +551633154577 jaqueline.gentil@gmail.com

Locations
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Brazil
Division of Cardiology, Department of Internal Medicine Recruiting
Ribeirao Preto, Sao Paulo, Brazil, 14000-000
Contact: Jaqueline RS Gentil, Master    +551633154577    jaqueline.gentil@usp.br   
Contact: Marcus V Simoes, PhD    +551636022791      
Sub-Investigator: Marcus Vinícius Simões, PhD         
Sub-Investigator: Pedro V Schwartzmann, PhD         
Sub-Investigator: Eduardo EV Carvalho, Master         
Sub-Investigator: Luciana P Seabra, Master         
Sub-Investigator: Júlio C Crescêncio, PhD         
Sub-Investigator: Lourenço Gallo Junior, PhD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Jaqueline RS Gentil, Master University of Sao Paulo
More Information
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Publications:

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Responsible Party: Jaqueline Rodrigues de Souza Gentil, Master degree, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02698046    
Other Study ID Numbers: 13/03301-1
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jaqueline Rodrigues de Souza Gentil, University of Sao Paulo:
Heart failure
Iron
Anemia
Chronic disease
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases