IV Ferric Carboxymaltose in Iron Deficiency in Chronic Heart Failure 1

• Research type

  Research Study

• Full title

  A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose with Placebo in Patients with Chronic Heart Failure and Iron Deficiency

• IRAS ID

  91071

• Contact name

  Theresa McDonagh

• Sponsor organisation

  Vifor (International) Inc.

• Eudract number

  2011-001695-19

• ISRCTN Number

  not known

• Research summary

  Recent evidence from clinical trials and observational data has indicated that the administration of iron intravenously (into a vein) in iron-depleted chronic heart failure patients may improve a number of clinical parameters including quality of life, aerobic fitness and iron-related blood variables. This study will compare the effectiveness of longer term intravenously (IV) administered iron therapy (ferric carboxymaltose) with that of IV placebo (inactive dummy medication) in adult iron-depleted stable chronic heart failure patients. The safety of this treatment will also be assessed. Approximately 300 patients will be enrolled into this study within Europe over a period of about 2 years. Eligible patients will be randomised (chosen by chance, like the flip of a coin) into one of two treatment arms:- Arm A: IV iron given as ferric carboxymaltose - Arm B: IV placebo Potential participants who have given written informed consent will attend the clinic for screening visits to assess their suitability for the study during the 4 weeks prior to the planned start of study treatment. Eligible patients will return to the clinic for assessments at the start of treatment (Week 0) and about 6 weeks, 12 weeks, 24 weeks, 36 weeks and 52 weeks after starting treatment with study medication. Study medication will be given by injection for up to 32 weeks The following procedures will be performed during the study: - patient assessment of quality of life and health - physical examinations - measurement of blood pressure and pulse rate - review of medication use - venous blood collection for safety and efficacy tests - ECG recording to monitor heart function - 6-minute walk tests to assess aerobic fitness - New York Heart Association (NYHA) functional class assessment At the end of the study, the study doctor will discuss alternative treatment options with the patient.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  11/LO/1795

• Date of REC Opinion

  10 Jan 2012

• REC opinion

  Further Information Favourable Opinion