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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Group | Experimental | Systolic heart failure patients received Ferrous Sulfate 200 mg t.i.d for 90 days |
|
| Control Group | Placebo Comparator | Systolic heart failure patients received placebo oral capsule t.i.d for 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate | Drug | Ferrous sulfate 200 mg t.i.d for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional Capacity | Six Minute Walk Test (meter) | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ferritin | Ferritin level (ng/mL) | 90 days |
| Transferrin saturation | Transferrin saturation (%) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bambang B Siswanto, Professor | National Cardiovascular Center Harapan Kita | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26028263 | Result | 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. | |
| 19920054 | 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. |
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| Placebo Oral Capsule | Drug | Lactose 200 mg t.i.d for 90 days |
|
| Haemoglobin | Haemoglobin level (gr/dL) | 90 days |
| Echocardiography parameters | Left Ventricle Ejection Fraction | 90 days |
| N Terminal-pro Brain Natriuretic Peptide | NT-proBNP level (pg/mL) | 90 days |
| 25639592 | 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. |
| 36578916 | Derived | 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. |
| ID | Term |
|---|---|
| D054143 | Heart Failure, Systolic |
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C020748 | ferrous sulfate |
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