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

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 |
- Biochemical 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 [ 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
- 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

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

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
Contact: Jaqueline RS Gentil, Master | +551633154577 | jaqueline.gentil@gmail.com |
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 |
Principal Investigator: | Jaqueline RS Gentil, Master | University of Sao Paulo |
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 |
Heart failure Iron Anemia Chronic disease |
Heart Failure Heart Diseases Cardiovascular Diseases |