EUCTR2011-000603-40-DE进行中（未招募）1 期
Multicentre, prospective, randomised, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency - EFFECT-HF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- •2. Reduced exercise capacity
- •3. Reduced left ventricular ejection fraction
- •4. At least 18 years of age and with written informed consent prior to any study specific procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 64
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 96
排除标准
- •1. Erythropoietin stimulating agent (ESA) use, IV iron therapy, and/or blood transfusion in previous 6 weeks prior to randomisation
- •2. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
- •3. Chronic liver disease and/or elevated liver enzymes
- •4. Vitamin B12 and/or serum folate deficiency that requires treatment
- •5. Subject is not using adequate contraceptive precautions during the study
- •6. No other significant cardiac or general disorder that would compromise participation in the study.
- •7. Subjects with body weight <35 kg
研究者
相似试验
进行中（未招募）
1 期
Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failureEUCTR2011-000603-40-BEVifor (International) Inc.160
进行中（未招募）
1 期
Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failureIron deficiency in patients with chronic heart failureMedDRA version: 16.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849MedDRA version: 16.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-000603-40-NLVifor (International) Inc.160
进行中（未招募）
1 期
Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failureIron deficiency in patients with chronic heart failureMedDRA version: 16.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849MedDRA version: 16.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-000603-40-ESVifor (International) Inc.160
进行中（未招募）
1 期
Multicentre, prospective, randomised, 2-arm study to assess the impact of ferric carboxymaltose on exercise capacity in chronic heart failure patients with iron deficiency - EFFECT-HFIron deficiency in patients with chronic heart failureMedDRA version: 14.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2011-000603-40-ITVIFOR (INTERNATIONAL) INC.174
已完成
3 期
Multicentre, Prospective, Randomised, 2-arm Study to Assess the Impact of Ferric Carboxymaltose on Exercise Capacity in Chronic Heart Failure Patients with Iron DeficiencyHart failure with Iron deficiency1001928010022958NL-OMON41512Vifor Pharma - Vifor (International) Inc.27