None listed
Conditions
Brief 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.
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.
Sponsors
Professor Andrew Sindone
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Chronic Heart Failure 2) Iron Deficiency 3) Patient willing and able to give consent
Exclusion criteria
1) Patients with a significant condition which will affect their clinical status such as terminal malignancy, HIV infection, etc 2) Pregnant patients 3) Patients unable to complete the Kansas City Cardiomyopathy Questionnaire, PHQ9 Questionnaire, or a 6-minute walk test 4) Patients that underwent a major change in clinical status including hospitalization or introduction of a new heart failure medication over the last month.
Outcome results
None listed