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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

Tracking Information
First Submitted Date  ICMJE December 16, 2015
First Posted Date  ICMJE March 3, 2016
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2016)
Biochemical parameter of serum transferrin saturation [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2016)
  • 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 [ Time Frame: 4 months ]
    Unit of measure mL/kg/min
  • Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing [ Time Frame: 4 months ]
    Unit of measure mL/kg/min
  • Ejection fraction of the left ventricle on doppler echocardiographic study [ Time Frame: 4 months ]
    Unit of measure %
  • Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels [ Time Frame: 4 months ]
  • Blood pressure results during mechanoreflex evaluation [ Time Frame: 4 months ]
    Unit of measure mmHg
  • Heart rate results during mechanoreflex evaluation [ Time Frame: 4 months ]
    Unit of measure beats per minute
  • Volume of oxygen consumed results during mechanoreflex evaluation [ Time Frame: 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 [ Time Frame: 4 months ]
    Score range 0 to 105 points
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2016)
  • Biochemical parameter of serum urea [ Time Frame: 4 months ]
    Unit of measure mg/dL
  • Biochemical parameter of serum creatinine [ Time Frame: 4 months ]
    Unit of measure mg/dL
  • Biochemical parameter of serum sodium [ Time Frame: 4 months ]
    Unit of measure mg/dL
  • Biochemical parameter of serum potassium [ Time Frame: 4 months ]
    Unit of measure mg/dL
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Oral Iron Therapy in Chronic Heart Failure Patients
Official Title  ICMJE Oral Iron Therapy in Chronic Heart Failure Patients: a Randomized, Placebo-controlled and Double-blind Clinical Trial (Pilot Study) of Efficiency
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Dietary Supplement: Ferrous sulfate
    200mg of ferrous sulfate three times a day for 4 months
  • Dietary Supplement: Placebo starch
    200mg of placebo starch three times a day for 4 months
Study Arms  ICMJE
  • Experimental: Ferrous sulfate
    Intervention: Dietary Supplement: Ferrous sulfate
  • Placebo Comparator: Placebo
    Intervention: Dietary Supplement: Placebo starch
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 28, 2016)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02698046
Other Study ID Numbers  ICMJE 13/03301-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jaqueline Rodrigues de Souza Gentil, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators  ICMJE
Principal Investigator: Jaqueline RS Gentil, Master University of Sao Paulo
PRS Account University of Sao Paulo
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP