NCT02698046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

December 16, 2015

Last Update Submit

February 28, 2016

Conditions

Heart Failure

Keywords

Heart failureIronAnemiaChronic disease

Outcome Measures

Primary Outcomes (1)

  • Biochemical parameter of serum transferrin saturation

    4 months

Secondary Outcomes (10)

  • Biochemical parameter of hemoglobin in the hemogram analysis

    4 months

  • Biochemical parameter of serum ferritin

    4 months

  • Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing

    4 months

  • Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing

    4 months

  • Ejection fraction of the left ventricle on doppler echocardiographic study

    4 months

  • +5 more secondary outcomes

Other Outcomes (4)

  • Biochemical parameter of serum urea

    4 months

  • Biochemical parameter of serum creatinine

    4 months

  • Biochemical parameter of serum sodium

    4 months

  • +1 more other outcomes

Study Arms (2)

Ferrous sulfate

EXPERIMENTAL
Dietary Supplement: Ferrous sulfate

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo starch

Interventions

Ferrous sulfateDIETARY_SUPPLEMENT

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

Ferrous sulfate
Placebo starchDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Department of Internal Medicine

Ribeirão Preto, São Paulo, 14000-000, Brazil

RECRUITING

Related Publications (3)

  • 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.

    PMID: 19920054BACKGROUND

  • 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.

    PMID: 20570952BACKGROUND

  • 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.

    PMID: 21903058BACKGROUND

MeSH Terms

Conditions

Heart FailureAnemiaChronic Disease

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jaqueline RS Gentil, Master

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaqueline RS Gentil, Master

CONTACT

+551633154577jaqueline.gentil@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master degree

Study Record Dates

First Submitted

December 16, 2015

First Posted

March 3, 2016

Study Start

August 1, 2015

Primary Completion

June 1, 2016

Study Completion

October 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)