Clinical trial NCT02998697: Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
Official title: The Effect of Short Term Oral Iron Supplementation in Systolic Heart Failure Patients Suffering From Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Heart Failure, Systolic
Iron-deficiency Anemia
Keywords: Systolic Heart Failure
Anemia
Iron Deficiency
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Functional Capacity
timeFrame: 90 days
Secondary outcomes:
measure: Ferritin
timeFrame: 90 days
measure: Transferrin saturation
timeFrame: 90 days
measure: Haemoglobin
timeFrame: 90 days
measure: Echocardiography parameters
timeFrame: 90 days
measure: N Terminal-pro Brain Natriuretic Peptide
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: National Cardiovascular Center Harapan Kita
name: Bambang B Siswanto, Professor
role: STUDY_DIRECTOR
References:
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.
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.
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.