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

December 19, 2016 updated by: Lita Dwi Suryani, National Cardiovascular Center Harapan Kita Hospital Indonesia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treated Group
Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days
Drug: Ferrous Sulfate
Ferrous sulfate 200 mg t.i.d for 90 days
Other Names:
  • Ferrous Sulfate oral capsule
Placebo Comparator: Control Group
Systolic heart failure patients received placebo oral capsule t.i.d for 90 days
Drug: Placebo Oral Capsule
Lactose 200 mg t.i.d for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Capacity
Time Frame: 90 days
Six Minute Walk Test (meter)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ferritin
Time Frame: 90 days
Ferritin level (ng/mL)
90 days
Transferrin saturation
Time Frame: 90 days
Transferrin saturation (%)
90 days
Haemoglobin
Time Frame: 90 days
Haemoglobin level (gr/dL)
90 days
Echocardiography parameters
Time Frame: 90 days
Left Ventricle Ejection Fraction
90 days
N Terminal-pro Brain Natriuretic Peptide
Time Frame: 90 days
NT-proBNP level (pg/mL)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Investigators

  • Study Director: Bambang B Siswanto, Professor, National Cardiovascular Center Harapan Kita

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 19, 2016

First Posted (Estimate)

December 20, 2016

Study Record Updates

Last Update Posted (Estimate)

December 20, 2016

Last Update Submitted That Met QC Criteria

December 19, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB.02.01/VII/077/KEP.033EV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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