Evaluation on Performance & Oxydative Stress in Patient With Iron

Status Completed

Clinical Trial Summary

ERADAL-HF is a double blinded, multi-centre, prospective, randomized, three arm study, enrolled ambulatory patients with chronic heart failure [New York Heart Association (NYHA) class II/III], with iron deficiency [defined as ferritin <100 ng/mL, or ferritin 100-300 ng/mL if transferrin saturation (TSAT) <20%] and haemoglobin (Hb) < 15 g/dL. Patients were randomized 1:1:1 to treatment into three arms: a first group treated with intravenous iron supplementation, a second treated by intramuscular iron supplementation and the third one which have received placebo. These patients were followed-up during a period of 04 weeks.

The aim of this study is to assess the short term effect of parenteral iron supplementation on exercise tolerance and oxidative stress in patients with stable chronic heart failure and iron deficiency

Clinical Trial Description

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04225728
Study type	Interventional
Source	Yaounde Central Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	December 1, 2017
Completion date	June 1, 2018

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation on Performance and Oxydative Stress in Patient With Iron deficIency and Stable Heart Failure Study — ERADAL-HF

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms