Chronic heart failure MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: FERINJECT*INF 5FL 2ML 50MG/ML
Pharmaceutical Form: Solution for injection
Other descriptive name: FERINJECT
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration numb
Sponsors
ISTITUTO AUXOLOGICO ITALIANO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Chronic heart failure - Left ventricular ejection fraction =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Acute heart failure - Uncontrolled hypertension - Unstable angina
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Test the hypothesis that parenteral iron therapy in patients with chronic heart failure and iron deficiency anemia absolute or functional chemoriflessa can improve the sensitivity and the patient's overall clinical condition;Secondary Objective: - Assess possible relationships between changes in the parameters of iron metabolism and clinical and functional responses to intravenous iron therapy. - Identify between the different indices of iron metabolism analyzed what could best predict positive response to parenteral iron supplementation and better characterize the behavior of the indices of iron;Primary end point(s): Evaluation of complete blood count and parameters of iron metabolism;Timepoint(s) of evaluation of this end point: 3 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a. | — |
Countries
Italy
Contacts
Public ContactU.O. Cardiologia
Istituto Auxologico Italiano
Outcome results
None listed