NL-OMON32525尚未招募3 期
A randomised, controlled, observer-blinded phase III clinical trial to compare the effect of intravenous ferric carboxymaltose to placebo on exercise capacity and cardiac function in patients with chronic heart failure and iron deficiency - EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac function in patients with iron deficiencY and chronic Heart Failure - EFFICACY-HF
Vifor Pharma - Vifor International AG0 个研究点目标入组 60 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Heart failure patients with EF 40% or lower, NYHA class II or III; Patients have been treated (unplanned hospitalisation or acute care admission) for congestive heart failure within last 24 months; Patients are treated for at least 4 weeks with standard heart failure medication, and 2 weeks without change in medication; Hemoglobin between 5,9 mmol/L and 8,4 mmol/L.
- •Ferritin < 100 microgram/L, or ferritin < 300 microgram/L and transferrin saturation < 20%.
排除标准
- •Anemia by other causes than iron deficiency, Unstable angina pectoris.
- •Walking distance limited by intermittent claudication.
- •Significant valvular disease or outflow tract obstruction.
- •Immunosuppressive therapy or renal dialysis.
- •Recent (within 12 weeks) myocardial infarction, percutaneous coronary intervention or CABG.
研究者
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