E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic heart failure |
Insufficienza cardiaca cronica |
|
E.1.1.1 | Medical condition in easily understood language |
Inability of the heart to supply adequate blood to the body |
Incapacità del cuore di fornire il sangue in quantità adeguata all'organismo |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
Testare l’ipotesi che la terapia marziale parenterale in pazienti con insufficienza cardiaca cronica, anemia e sideropenia assoluta o funzionale possa migliorare la sensibilità chemoriflessa e la condizione clinica complessiva del paziente |
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E.2.2 | Secondary objectives of the trial |
- 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 |
- Valutare possibili relazioni tra i cambiamenti dei parametri del metabolismo del ferro e le risposte clinico-funzionali alla terapia marziale endovenosa. - Identificare tra i differenti indici del metabolismo del ferro analizzati quello che potrebbe meglio predire la risposta positiva alla supplementazione marziale parenterale e meglio caratterizzare il comportamento degli indici del ferro |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Chronic heart failure - Left ventricular ejection fraction <= 45% - Iron-deficiency anemia |
- Insufficienza cardiaca cronica - Frazione di eiezione ventricolare sinistra <=45% - Sideropenia |
|
E.4 | Principal exclusion criteria |
- Acute heart failure - Uncontrolled hypertension - Unstable angina |
- Scompenso cardiaco acuto - Ipertensione arteriosa non controllata - Angina instabile |
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E.5 End points |
E.5.1 | Primary end point(s) |
Evaluation of complete blood count and parameters of iron metabolism |
Valutazione dell’emocromo e dei parametri del metabolismo del ferro |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Evaluate the effect of iron therapy in patients with chronic heart failure |
Valutare effetto della terapia marziale in pazienti con insufficienza cardiaca cronica |
|
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 36 |
E.8.9.1 | In the Member State concerned days | 0 |