To assess impact on left ventricular reverse remodeling defined as a change in left ventricular ejection fraction in heart failure patients with reduced ejection fraction (and previous implantation of cardiac resynchronization therapy) undergoing treatment with ferric carboxymaltose vs. placebo
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Ferric carboxymaltose will be administered according to product specification dosing
IV nacl 0.9%
Pieter Martens
Genk, Limburg, Belgium
Change in left ventricular ejection fraction from baseline
delta\_LVEF measured by 3D-echocardiography
Time frame: 3 months
Change in left ventricular end systolic volume from baseline
delta\_LVESV measured by 3D-echocardiography
Time frame: 3 months
Change in left ventricular end diastolic volume from baseline
delta\_LVEDV measured by 3D-echocardiography
Time frame: 3 months
Force frequency relationship
measured by 2D-echocardiography
Time frame: 3 months
Heart failure hospitalization and all-cause mortality
measured by telephone contact
Time frame: Up to six months
Incidence of Treatment-associated Serious and non-serious adverse events.
Serious and non-serious adverse events (AE) will be registered, which include:start date AE, duration AE, end-date AE, treatment group, continuation of AE after dose interruption, causality with study medication, presence of risk factors for AE and response to AE (sequela or recovery).
Time frame: During intravenous study drug administration and 1-hour in hospital follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.