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Heart FailurePhase 3NCT02698046

Oral Iron Therapy in Chronic Heart Failure Patients

A Phase 3 study testing Ferrous sulfate in people with Heart Failure, run by University of Sao Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Ferrous sulfate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
1 siteBrazil
Study dates
Aug 2015to Oct 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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).

Trial locations and contacts

1 site in 1 country.

Jaqueline RS Gentil, Master contact

+551633154577

jaqueline.gentil@gmail.com

Brazil1 site, 1 recruiting

  • Division of Cardiology, Department of Internal Medicine

    Ribeirão Preto, São Paulo, 14000-000

    Jaqueline RS Gentil, Master, +551633154577, jaqueline.gentil@usp.br

    Marcus V Simoes, PhD, +551636022791

    Recruiting

Other trials in Brazil

About this study

Official title: Oral Iron Therapy in Chronic Heart Failure Patients: a Randomized, Placebo-controlled and Double-blind Clinical Trial (Pilot Study) of Efficiency

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.

Read the 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.

Conditions
Heart Failure
Being tested
Ferrous sulfate, Placebo starch
Keywords
Heart failure, Iron, Anemia, Chronic disease
Medical subject headings
Heart Failure, Anemia, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferrous sulfateDietary supplement

    200mg of ferrous sulfate three times a day for 4 months

  • Placebo starchDietary supplement

    200mg of placebo starch three times a day for 4 months

Study groups in NCT02698046
Study groupRoleWhat they receive
Ferrous sulfateExperimentalNot described
Receives: Dietary Supplement: Ferrous sulfate
PlaceboPlacebo comparatorNot described
Receives: Dietary Supplement: Placebo starch

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biochemical parameter of serum transferrin saturation

    Measured: 4 months

Secondary outcomes (10)

  1. Biochemical parameter of hemoglobin in the hemogram analysis

    Measured: 4 months

  2. Biochemical parameter of serum ferritin

    Measured: 4 months

  3. Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing

    Unit of measure mL/kg/min

    Measured: 4 months

  4. Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing

    Unit of measure mL/kg/min

    Measured: 4 months

  5. Ejection fraction of the left ventricle on doppler echocardiographic study

    Unit of measure %

    Measured: 4 months

  6. Biochemical parameter of N-terminal pro-brain natriuretic peptide (NT-pro-BNP) serum levels

    Measured: 4 months

  7. Blood pressure results during mechanoreflex evaluation

    Unit of measure mmHg

    Measured: 4 months

  8. Heart rate results during mechanoreflex evaluation

    Unit of measure beats per minute

    Measured: 4 months

  9. Volume of oxygen consumed results during mechanoreflex evaluation

    Unit of measure mL/kg/min

    Measured: 4 months

  10. Total score of physical, emotional, and overall dimensions domains of the Minnesota Living with Heart Failure Questionnaire

    Score range 0 to 105 points

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startAug 2015
  3. Primary completionJun 2016 (estimated)
  4. Study completionOct 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02698046
Sponsor's protocol ID
13/03301-1
Status last verified
Feb 2016
First submitted
16 Dec 2015
Last updated
3 Mar 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.

    PubMed 19920054

  • Jankowska EA, Rozentryt P, Witkowska A, Nowak J, Hartmann O, Ponikowska B, Borodulin-Nadzieja L, Banasiak W, Polonski L, Filippatos G, McMurray JJ, Anker SD, Ponikowski P. Iron deficiency: an ominous sign in patients with systolic chronic heart failure. Eur Heart J. 2010 Aug;31(15):1872-80. doi: 10.1093/eurheartj/ehq158. Epub 2010 Jun 21.

    PubMed 20570952

  • Okonko DO, Mandal AK, Missouris CG, Poole-Wilson PA. Disordered iron homeostasis in chronic heart failure: prevalence, predictors, and relation to anemia, exercise capacity, and survival. J Am Coll Cardiol. 2011 Sep 13;58(12):1241-51. doi: 10.1016/j.jacc.2011.04.040.

    PubMed 21903058

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferrous sulfate in people with Heart Failure, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaqueline RS Gentil, Master (+551633154577, jaqueline.gentil@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biochemical parameter of serum transferrin saturation (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698046, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2016.

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