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

NCT02998697 | Completed Phase 2 DMC

• 1 other identifier: LB.02.01/VII/077/KEP.033EV
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Heart Failure, Systolic; Iron-deficiency Anemia

Keywords

Systolic Heart Failure; Anemia; Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Functional Capacity

  Six Minute Walk Test (meter)

  90 days

Secondary Outcomes (5)

• Ferritin

  90 days

• Transferrin saturation

  90 days

• Haemoglobin

  90 days

• Echocardiography parameters

  90 days

• N Terminal-pro Brain Natriuretic Peptide

  90 days

Study Arms (2)

Treated Group

EXPERIMENTAL

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

Drug: Ferrous Sulfate

Control Group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Capsule

Interventions

Ferrous Sulfate DRUG

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

Also known as: Ferrous Sulfate oral capsule

Treated Group

Placebo Oral Capsule DRUG

Lactose 200 mg t.i.d for 90 days

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cardiovascular Center Harapan Kita Hospital Indonesia: lead

Related Publications (4)

• 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.

  PMID: 26028263 RESULT

• 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: 19920054 RESULT

• 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.

  PMID: 25639592 RESULT

• Suryani LD, Raharjo SB, Sagita R, Angkasa H, Prasetyadi YL, Suyatna FD, Hersunarti N, Soerarso R, Siswanto BB, Muliawan HS. Oral Ferrous Sulphate Improves Functional Capacity on Heart Failure Patients with Iron Deficiency Anemia. Glob Heart. 2022 Nov 22;17(1):81. doi: 10.5334/gh.1151. eCollection 2022.

  PMID: 36578916 DERIVED

MeSH Terms

Conditions

Heart Failure, Systolic; Anemia, Iron-Deficiency; Anemia; Iron Deficiencies

Interventions

ferrous sulfate

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Anemia, Hypochromic; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Bambang B Siswanto, Professor

  National Cardiovascular Center Harapan Kita

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 20, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 20, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share