TerminatedPhase 2ACTRN12615000952549

Iron Infusion in Heart Failure Study

A Randomized Controlled Study of Ferric Carboxymaltose versus Placebo in Patients with Heart Failure on Short Term Outcomes including quality of life, exercise tolerance, hemodynamic indices, serum BNP and ST2 levels


Sponsor

Professor Andrew Sindone

Enrollment

82 participants

Start Date

Jul 1, 2015

Study Type

Interventional

Conditions

Summary

The purpose of our current study is to characterize the immediate short term impact of iron repletion on heart failure patients’ quality of life, exercise tolerance, hemodynamic indices, and serum BNP and ST2 levels; this will in turn add to the growing body of evidence supporting the investigation and treatment of iron deficiency in patients with congestive cardiac failure. Our hypothesis is that intravenous ferric carboxymaltose in congestive cardiac failure patients with concomitant iron deficiency will improve quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire Score), short term exercise capacity (as measured on the six minute walk test), hemodynamic indices (as measured via impedance cardiography), and blood profile (BNP and ST2 levels )when compared with a placebo infusion of 0.9% sodium chloride.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria3

  • Chronic Heart Failure
  • Iron Deficiency
  • Patient willing and able to give consent

Exclusion Criteria4

  • Patients with a significant condition which will affect their clinical status such as terminal malignancy, HIV infection, etc
  • Pregnant patients
  • Patients unable to complete the Kansas City Cardiomyopathy Questionnaire, PHQ9 Questionnaire, or a 6-minute walk test
  • Patients that underwent a major change in clinical status including hospitalization or introduction of a new heart failure medication over the last month.

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Interventions

The intervention is 1000mg (20mL) of Ferric Carboyxmaltose, diluted in 250mL of 0.9% NaCl, administered intravenously via an intravenous cannula over 15 minutes as a once-off infusion.

The intervention is 1000mg (20mL) of Ferric Carboyxmaltose, diluted in 250mL of 0.9% NaCl, administered intravenously via an intravenous cannula over 15 minutes as a once-off infusion.


Locations(1)

Concord Repatriation Hospital - Concord

NSW, Australia

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