Congestive heart failure (CHF) MedDRA version: 16.1 Level: LLT Classification code 10019284 Term: Heart failure, congestive System Organ Class: 100000004849
Conditions
Interventions
Trade Name: Ferinject 50 mg Eisen/ml
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: ferric carboxymaltose
CAS Number: 0009007-72-1
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Universitätsklinikum Ulm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Congestive heart failure -at least 18 years of age -iron deficiency -NYHA class II or III -LVEF =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: -Known sensitivity to any of the products to be administered during dosing -immediate need of transfusion -patients presenting with an active infection -Thalassaemia -other forms of microcytic anemia not caused by iron deficiency - history of acquired iron overload -need for revascularization -STEMI or Non-STEMI during the past 4 months -women who are pregnant or of childbearing age and not using medically acceptable effective contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve LV-EF in patients with CHF and iron deficiency as determined by cardiac MRI.;Secondary Objective: Not applicable;Primary end point(s): Change from baseline to week 12 in left-ventricular ejection fraction (LV-EF) as determined by cardiac-MRI. If MRI is not feasible due to cardiac metal implants (like pace-maker or heart defibrillator) another appropriate routine method may be used, like cardiac computed tomography (CT) (expected in a maximum of 5 from 100 subjects).;Timepoint(s) of evaluation of this end point: Visit 3: Week 12 ( day 84 ± 14 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline to week 12 in: - semi-quantitative perfusion measurement by cardiac-MRI - ventricular and atrial diameters and wall thickness as quantified by cardiac-MRI - glomerular filtration rate as determined by radionuclide measurement - NYHA class - 6 min walk test - key laboratory and iron parameters (including Hb, serum ferritin, TSAT) - cardiac biomarkers (including NT-proBNP) - QoL (KCCQ and EQ-5D) questionnaires - Percentage of patients meeting key safety endpoint defined as time to death, first hospitalization for worsening heart failure, myocardial infarction, angina pectoris and stroke ;Timepoint(s) of evaluation of this end point: Visit 3: Week 12 ( day 84 ± 14 days) | — |
Countries
Germany
Contacts
Public ContactMahir Karakas
Universitäres Herzzentrum Hamburg
Outcome results
None listed