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Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia (IRON5)

Primary Purpose

Heart Failure, Systolic, Iron-deficiency Anemia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ferrous Sulfate

Placebo Oral Capsule

About this trial

This is an interventional treatment trial for Heart Failure, Systolic focused on measuring Systolic Heart Failure, Anemia, Iron Deficiency

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 year old
Systolic heart failure patients without clinical sign of decompensation at outpatient clinic
New York Heart Association (NYHA) functional class II-III able to perform 6MWT
LVEF < 50%
On heart failure therapy
Haemoglobin (Hb) < 13 gr/dL (male); Hb < 12 gr/dL (female) and > 8 gr/dL
Ferritin < 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) < 20%
Agree to participate

Exclusion Criteria:

History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer
History of myocardial revascularization (CABG/PCI) within 3 month
Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month
Know to have allergic reaction to Ferrous sulfate
History of intravenous iron administration within 1 month
Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT)
estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2
NT-proBNP > 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP < 30% from baseline
Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)> 3x normal value
Moderate to severe primary valvular heart disease
Congenital heart disease
Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treated Group

Control Group

Arm Description

Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days

Systolic heart failure patients received placebo oral capsule t.i.d for 90 days

Outcomes

Primary Outcome Measures

Functional Capacity

Six Minute Walk Test (meter)

Secondary Outcome Measures

Ferritin

Ferritin level (ng/mL)

Transferrin saturation

Transferrin saturation (%)

Haemoglobin

Haemoglobin level (gr/dL)

Echocardiography parameters

Left Ventricle Ejection Fraction

N Terminal-pro Brain Natriuretic Peptide

NT-proBNP level (pg/mL)

Full Information

NCT ID

NCT02998697

First Posted

December 14, 2016

Last Updated

December 19, 2016

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

1. Study Identification

Unique Protocol Identification Number

NCT02998697

Brief Title

Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

Acronym

IRON5

Official Title

The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2016 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine the efficacy of Ferrous Sulphate (FS) tablets in improving iron stores and functional capacity in HF patients with Iron Deficiency Anemia (IDA).

Detailed Description

The investigators conducted a double blind randomized controlled trial (RCT) enrolling 54 Heart Failure (HF) patients (LVEF < 50%) with IDA (Ferritin < 100 ng/mL or 100-300 ng/mL with Tsat < 20%) at outpatient clinic of National Cardiovascular Center Harapan Kita from January to July 2016. Patients were randomized 1:1 to received FS or placebo for 90 days, the investigators then evaluated the change in 6-Minute Walking Test (6MWT) distance as primary end-point and changes on N-Terminal-pro Brain Natriuretic Peptide (NT-proBNP) and post 6MWT serum lactate levels as secondary end-points.

6. Conditions and Keywords

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

Heart Failure, Systolic, Iron-deficiency Anemia

Keywords

Systolic Heart Failure, Anemia, Iron Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treated Group

Arm Type

Experimental

Arm Description

Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days

Arm Title

Control Group

Arm Type

Placebo Comparator

Arm Description

Systolic heart failure patients received placebo oral capsule t.i.d for 90 days

Intervention Type

Drug

Intervention Name(s)

Ferrous Sulfate

Other Intervention Name(s)

Ferrous Sulfate oral capsule

Intervention Description

Ferrous sulfate 200 mg t.i.d for 90 days

Intervention Type

Drug

Intervention Name(s)

Placebo Oral Capsule

Intervention Description

Lactose 200 mg t.i.d for 90 days

Primary Outcome Measure Information:

Title

Functional Capacity

Description

Six Minute Walk Test (meter)

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Ferritin

Description

Ferritin level (ng/mL)

Time Frame

90 days

Title

Transferrin saturation

Description

Transferrin saturation (%)

Time Frame

90 days

Title

Haemoglobin

Description

Haemoglobin level (gr/dL)

Time Frame

90 days

Title

Echocardiography parameters

Description

Left Ventricle Ejection Fraction

Time Frame

90 days

Title

N Terminal-pro Brain Natriuretic Peptide

Description

NT-proBNP level (pg/mL)

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 year old Systolic heart failure patients without clinical sign of decompensation at outpatient clinic New York Heart Association (NYHA) functional class II-III able to perform 6MWT LVEF < 50% On heart failure therapy Haemoglobin (Hb) < 13 gr/dL (male); Hb < 12 gr/dL (female) and > 8 gr/dL Ferritin < 100 µg/L or Ferritin 100-300 µg/L dengan Transferrin saturation (Tsat) < 20% Agree to participate Exclusion Criteria: History of : active bleeding,infection, malignancy, haematological abnormality, peptic ulcer History of myocardial revascularization (CABG/PCI) within 3 month Acute Coronary Syndrome (ACS), stroke,Transient Ischemic Attack (TIA) within 3 month Know to have allergic reaction to Ferrous sulfate History of intravenous iron administration within 1 month Permanent Pace Maker(PPM)/Implantable Cardiac Defibrillator (ICD)/Cardiac Resynchronization Therapy (CRT) estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 NT-proBNP > 4000 pg/ml (for patients without baseline data) or decreased level of NT-proBNP < 30% from baseline Increase level of serum alanine aminotransferase (ALT)/ serum aspartate aminotransferase (AST)> 3x normal value Moderate to severe primary valvular heart disease Congenital heart disease Right heart failure due to primary pulmonary hypertension, cor pulmonale, Chronic Thrombo-Embolic Pulmonary Hypertension (CTEPH)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bambang B Siswanto, Professor

Organizational Affiliation

National Cardiovascular Center Harapan Kita

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26028263

Citation

Niehaus ED, Malhotra R, Cocca-Spofford D, Semigran M, Lewis GD. Repletion of Iron Stores With the Use of Oral Iron Supplementation in Patients With Systolic Heart Failure. J Card Fail. 2015 Aug;21(8):694-7. doi: 10.1016/j.cardfail.2015.05.006. Epub 2015 May 29.

Results Reference

result

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

result

PubMed Identifier

25639592

Citation

McDonagh T, Macdougall IC. Iron therapy for the treatment of iron deficiency in chronic heart failure: intravenous or oral? Eur J Heart Fail. 2015 Mar;17(3):248-62. doi: 10.1002/ejhf.236. Epub 2015 Jan 30.

Results Reference

result

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Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia

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