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临床试验/CTRI/2021/02/031307
CTRI/2021/02/031307已完成未知

Prospective ObseRvational Study to Assess Effectiveness and Safety of IntravenousFerric Carboxymaltose 1000 mg in Patients of Chronic Heart Failure with IronDeficiEncy - PRIDE-HF Study - PRIDE-HF

Emcure Pharmaceuticals Limited0 个研究点目标入组 98 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
98

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • 1.Indian adult ( > 18 years of age) patients of either gender who are capable of complying with
  • study protocol requirements.
  • 2. Stable symptomatic ambulatory patients diagnosed with chronic heart failure of New York Heart Association (NYHA) class II â?? III and iron deficiency. Iron deficiency is diagnosed whenthe serum ferritin level is lessthan 100 μg/L or is between 100 and 299 μg/L when the transferrin saturation (TSAT) is less than 20%.
  • 3. Patients ready to give informed consent for participation in study.

排除标准

  • 1. Patients not willing to sign Informed Consent Form and provide medical data.
  • 2. Hypersensitivity to ferric carboxymaltose injection.
  • 3. Participation in any other clinical trial in the past 3 months.
  • 4. Treatment with other IV Iron preparations within 4 weeks prior to study enrolment.
  • 5. Any condition that, in the opinion of the investigator, does not justify the patientâ??s inclusion in the study.

研究者

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