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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).


Clinical Trial 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. ;


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


NCT number NCT02998697
Study type Interventional
Source National Cardiovascular Center Harapan Kita Hospital Indonesia
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 2016
Completion date November 2016

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