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Oral Iron Therapy in Chronic Heart Failure Patients

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Ferrous sulfate

Placebo starch

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart failure, Iron, Anemia, Chronic disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Division of Cardiology, Department of Internal MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ferrous sulfate

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Biochemical parameter of serum transferrin saturation

Secondary Outcome Measures

Biochemical parameter of hemoglobin in the hemogram analysis

Biochemical parameter of serum ferritin

Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing

Unit of measure mL/kg/min

Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing

Unit of measure mL/kg/min

Ejection fraction of the left ventricle on doppler echocardiographic study

Unit of measure %

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

Blood pressure results during mechanoreflex evaluation

Unit of measure mmHg

Heart rate results during mechanoreflex evaluation

Unit of measure beats per minute

Volume of oxygen consumed results during mechanoreflex evaluation

Unit of measure mL/kg/min

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

Score range 0 to 105 points

Full Information

NCT ID

NCT02698046

First Posted

December 16, 2015

Last Updated

February 28, 2016

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT02698046

Brief Title

Oral Iron Therapy in Chronic Heart Failure Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

August 2015 (undefined)

Primary Completion Date

June 2016 (Anticipated)

Study Completion Date

October 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

Heart failure, Iron, Anemia, Chronic disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ferrous sulfate

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Ferrous sulfate

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo starch

Intervention Description

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

Primary Outcome Measure Information:

Title

Biochemical parameter of serum transferrin saturation

Time Frame

4 months

Secondary Outcome Measure Information:

Title

Biochemical parameter of hemoglobin in the hemogram analysis

Time Frame

4 months

Title

Biochemical parameter of serum ferritin

Time Frame

4 months

Title

Volume of oxygen consumed at peak exercise during cardiopulmonary exercise testing

Description

Unit of measure mL/kg/min

Time Frame

4 months

Title

Volume of oxygen consumed at anaerobic threshold during cardiopulmonary exercise testing

Description

Unit of measure mL/kg/min

Time Frame

4 months

Title

Ejection fraction of the left ventricle on doppler echocardiographic study

Description

Unit of measure %

Time Frame

4 months

Title

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

Time Frame

4 months

Title

Blood pressure results during mechanoreflex evaluation

Description

Unit of measure mmHg

Time Frame

4 months

Title

Heart rate results during mechanoreflex evaluation

Description

Unit of measure beats per minute

Time Frame

4 months

Title

Volume of oxygen consumed results during mechanoreflex evaluation

Description

Unit of measure mL/kg/min

Time Frame

4 months

Title

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

Description

Score range 0 to 105 points

Time Frame

4 months

Other Pre-specified Outcome Measures:

Title

Biochemical parameter of serum urea

Description

Unit of measure mg/dL

Time Frame

4 months

Title

Biochemical parameter of serum creatinine

Description

Unit of measure mg/dL

Time Frame

4 months

Title

Biochemical parameter of serum sodium

Description

Unit of measure mg/dL

Time Frame

4 months

Title

Biochemical parameter of serum potassium

Description

Unit of measure mg/dL

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jaqueline RS Gentil, Master

Phone

+551633154577

jaqueline.gentil@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaqueline RS Gentil, Master

Organizational Affiliation

University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Cardiology, Department of Internal Medicine

City

Ribeirao Preto

State/Province

Sao Paulo

ZIP/Postal Code

14000-000

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaqueline RS Gentil, Master

Phone

+551633154577

jaqueline.gentil@usp.br

First Name & Middle Initial & Last Name & Degree

Marcus V Simoes, PhD

Phone

+551636022791

First Name & Middle Initial & Last Name & Degree

Marcus Vinícius Simões, PhD

First Name & Middle Initial & Last Name & Degree

Pedro V Schwartzmann, PhD

First Name & Middle Initial & Last Name & Degree

Eduardo EV Carvalho, Master

First Name & Middle Initial & Last Name & Degree

Luciana P Seabra, Master

First Name & Middle Initial & Last Name & Degree

Júlio C Crescêncio, PhD

First Name & Middle Initial & Last Name & Degree

Lourenço Gallo Junior, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

19920054

Citation

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.

Results Reference

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PubMed Identifier

20570952

Citation

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. Erratum In: Eur Heart J. 2011 May;32(9):1054.

Results Reference

background

PubMed Identifier

21903058

Citation

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.

Results Reference

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Oral Iron Therapy in Chronic Heart Failure Patients

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