NCT02998697

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

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure, Systolic
• Iron-deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferrous Sulfate	Ferrous sulfate 200 mg t.i.d for 90 days
DRUG	Placebo Oral Capsule	Lactose 200 mg t.i.d for 90 days

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2016-12-20
• Last updated: 2016-12-20