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

NCT ID: NCT02998697

Last Updated: 2016-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-11-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Heart Failure, Systolic Iron-deficiency Anemia

Keywords

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Systolic Heart Failure Anemia Iron Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treated Group

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

Group Type EXPERIMENTAL

Ferrous Sulfate

Intervention Type DRUG

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

Control Group

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

Group Type PLACEBO_COMPARATOR

Placebo Oral Capsule

Intervention Type DRUG

Lactose 200 mg t.i.d for 90 days

Interventions

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Ferrous Sulfate

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

Intervention Type DRUG

Placebo Oral Capsule

Lactose 200 mg t.i.d for 90 days

Intervention Type DRUG

Other Intervention Names

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Ferrous Sulfate oral capsule

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Lita Dwi Suryani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bambang B Siswanto, Professor

Role: STUDY_DIRECTOR

National Cardiovascular Center Harapan Kita

References

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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.

Reference Type RESULT
PMID: 26028263 (View on PubMed)

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.

Reference Type RESULT
PMID: 19920054 (View on PubMed)

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.

Reference Type RESULT
PMID: 25639592 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36578916 (View on PubMed)

Other Identifiers

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LB.02.01/VII/077/KEP.033EV

Identifier Type: -

Identifier Source: org_study_id