Heart Diseases Clinical Trial
Official title:
A Randomised Controlled Study to Assess the Acute and Chronic Effects of Intravenous Iron Supplementation in Anaemic and Non-Anaemic Iron Deficient Patients With Chronic Heart Failure
This is a two-center, randomised, single-blind (physician), prospective, controlled study to
assess the acute (8 weeks) and chronic (16 weeks) effects of intravenous (IV) iron sucrose
supplementation in anaemic and non-anaemic iron deficient patients with chronic heart
failure (CHF).
The hypotheses are:
- Treatment of anaemic and non-anaemic iron-deficient CHF patients with IV iron sucrose
improves exercise capacity as measured by peak VO2.
- IV iron sucrose is safe and well tolerated in subjects with moderate to severe CHF.
Study Phase and Design:
Prospective two-centre, randomized, controlled, open-label, observer-blinded, parallel-group
study
Primary Objective:
To evaluate the effect of intravenous (IV) iron supplementation on exercise tolerance, as
determined by peak VO2.
Secondary Objectives:
- To evaluate the effects of IV iron supplementation on exercise duration, left
ventricular (LV) structure and function, symptom status (NYHA class, Minnesota Living
with Heart Failure Questionnaire [MLHFQ], and subjective fatigue score), and
haematological and biochemical (haemoglobin [Hb], haematocrit [Hct], iron status,
N-BNP, cytokines and oxidative stress) indices.
- To evaluate the safety profile of IV iron in subjects with moderate to severe CHF.
Sample Size:
42 subjects (28 IV iron, 14 placebo); 50% anaemic and 50% non-anaemic
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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