NCT00125996Unknown1 期
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
National Heart and Lung Institute4 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2004年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Change in peak VO2 from baseline to week 18
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 30 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥21 years of age and have signed written informed consent
- •Stable symptomatic CHF; NYHA III/IV and left ventricular ejection fraction (LVEF) ≤40%, or if NYHA II then LVEF must be ≤35%, as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
- •On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
- •Peak VO2 ≤ 18 ml/kg/min on modified Naughton protocol cardiopulmonary exercise testing.
- •Mean of the 2 screening Hb concentrations (week-2 and week-1) < 12.5 g/dl (anaemic group, 50% of study population) or 12.5-14.0 g/dl (non-anaemic group, 50% of study population).
- •Ferritin <100 µg/l or 100-300 µg/l with TSAT <20%.
- •Normal red cell folate and vitamin B12 status (according to local lab reference range).
- •Resting blood pressure ≤160/100 mmHg.
排除标准
- •History of acquired iron overload; known haemochromatosis or first relatives with haemochromatosis; and allergic disorders (asthma, eczema, and anaphylactic reactions).
- •Known hypersensitivity to parental iron preparations.
- •Known active infection, bleeding, malignancy and haemolytic anaemia.
- •History of chronic liver disease and/or alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range; chronic lung disease; myelodysplastic disorder; and known HIV/AIDS disease.
- •Recipient of immunosuppressive therapy or renal dialysis.
- •History of erythropoietin, IV or oral iron therapy, and blood transfusion in previous 30 days.
- •Unstable angina pectoris, as judged by the investigator; severe uncorrected valvular disease or left ventricular outflow obstruction; obstructive cardiomyopathy; uncontrolled fast atrial fibrillation or flutter (heart rate >110 beats per minute [bpm]); uncontrolled symptomatic brady- or tachyarrhythmias.
- •Musculoskeletal limitation that, in the judgement of the investigator, would impair cardiopulmonary exercise testing.
- •Pregnant or breast-feeding
- •Inability to comprehend study protocol
- •Parallel participation in another clinical trial
结局指标
主要结局
Change in peak VO2 from baseline to week 18
次要结局
- Change in cardiopulmonary exercise duration from baseline to week 18
- Change in left ventricular (LV) systolic and diastolic dimensions, and function from baseline to week 18
- Change in symptom status (New York Heart Association [NYHA] class, Minnesota Living with Heart Failure Questionnaire [MLHFQ], visual analogue fatigue scale) from baseline to week 1,week 8, and week 18
- Change in haematological and biochemical indices (Hb, Hct, iron status, N-BNP, cytokines and oxidative stress) from baseline to week 18
- Number and incidence of adverse events
- Changes in liver function tests and renal function tests
- Changes in vital parameters
- Change in distance walked during 6 minute walk test from baseline to end of repletion phase in treatment group or week 8 in control group, and week 18
研究者
研究点 (4)
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