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

Heart Failure, Systolic Clinical Trial

— IRON5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998697
• Other study ID #: LB.02.01/VII/077/KEP.033EV
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 14, 2016
• Last updated: December 19, 2016
• Start date: January 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Indonesia: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Heart Failure
• Heart Failure, Systolic
• Iron-deficiency Anemia

Intervention

Drug:
• Ferrous Sulfate
Ferrous sulfate 200 mg t.i.d for 90 days
• Placebo Oral Capsule
Lactose 200 mg t.i.d for 90 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Cardiovascular Center Harapan Kita Hospital Indonesia

References & Publications (3)

Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Lüscher 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 carboxymal — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Capacity	Six Minute Walk Test (meter)	90 days	Yes
Secondary	Ferritin	Ferritin level (ng/mL)	90 days	Yes
Secondary	Transferrin saturation	Transferrin saturation (%)	90 days	Yes
Secondary	Haemoglobin	Haemoglobin level (gr/dL)	90 days	Yes
Secondary	Echocardiography parameters	Left Ventricle Ejection Fraction	90 days	Yes
Secondary	N Terminal-pro Brain Natriuretic Peptide	NT-proBNP level (pg/mL)	90 days	Yes