E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Iron deficiency in patients with chronic heart failure |
Ferropenia en pacientes con insuficiencia cardíaca crónica |
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E.1.1.1 | Medical condition in easily understood language |
Iron deficiency in patients with chronic heart failure |
Ferropenia en pacientes con insuficiencia cardíaca crónica |
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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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008908 |
E.1.2 | Term | Chronic heart failure |
E.1.2 | System Organ Class | 10007541 - Cardiac disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022970 |
E.1.2 | Term | Iron deficiency |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition 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 |
1. To determine, relative to placebo, the effect of iron repletion therapy using intrravenous (IV) FCM on exercise capacity assessed by 6-minute walk test (6MWT) at 24 weeks after initiation of therapy in subjects with CHF and ID |
1. Determinar, en comparación con placebo, el efecto del tratamiento de reposición del hierro con CMF por vía intravenosa (IV) sobre la capacidad de hacer ejercicio evaluada mediante la prueba de marcha durante 6 minutos (6MWT) 24 semanas después del inicio del tratamiento en pacientes con ICC y ferropenia. |
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E.2.2 | Secondary objectives of the trial |
1. To evaluate the effect of IV FCM compared to placebo on New York Heart Association (NYHA) functional class.
2. To evaluate the effect of IV FCM compared to placebo on relevant biomarkers/laboratory parameters.
3. To evaluate the effect of IV FCM compared to placebo on health related quality of life (QoL).
4. To evaluate the tolerability and safety of IV FCM compared to placebo. |
1. Evaluar el efecto de la CMF IV en comparación con placebo sobre la clase funcional de la New York Heart Association (NYHA).
2. Evaluar el efecto de la CMF IV en comparación con placebo sobre biomarcadores/parámetros analíticos pertinentes.
3. Evaluar el efecto de la CMF IV en comparación con placebo sobre la calidad de vida (CdV) relacionada con la salud.
4. Evaluar la tolerabilidad y la seguridad de la CMF IV en comparación con placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF 2. Reduced left ventricular ejection fraction 3. Capable of completing 6 minute walk test (6MWT) 4. At least 18 years of age and with written informed consent prior to any study specific procedures |
1.Pacientes con ferropenia y con ICC estable (clase funcional II-III de la NYHA) con un tratamiento de fondo óptimo. 2.Fracción de eyección del ventrículo izquierdo ? 45% 3.El paciente ha de ser capaz de completar la 6MWT 4. Edad mínima de 18 años y consentimiento informado por escrito antes de realizar ningún procedimiento específico del estudio |
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E.4 | Principal exclusion criteria |
1. Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation. 2. Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months 3.Chronic liver disease and/or elevated liver enzymes 4. Vitamin B12 and/or serum folate deficiency 5. Subject is not using adequate contraceptive precautions during the study 6. Body weight ?35 kg 7. No other significant cardiac or general disorders that would comprise the ability to give informed consent and/or comply with study procedures |
1. Antecedentes de tratamiento con medicamentos estimuladores de la eritropoyesis, tratamiento con hierro IV o transfusión de sangre en las 6 semanas anteriores a la aleatorización. 2. Programa de entrenamiento con ejercicio en los 3 meses anteriores a la selección o previsto en los 6 meses siguientes. 3. Hepatopatía crónica y/o niveles de enzimas hepáticos elevados 4. Deficiencia de vitamina B12 o folato sérico 5.El paciente no se muestra dispuesto a utilizar precauciones anticonceptivas suficientes durante el estudio y durante un máximo de 5 días después de la última dosis programada de medicación del estudio. 6.Peso corporal menor o igual a 35 Kg. 7. Algún tipo de trastorno general o cardiaco que compromete su capacidad para otorgar su consentimiento informado por escrito o para cumplir los procedimientos del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in 6 minute walk test (6MWT) from baseline to Week 24 visit after start of investigational drug |
Variación de la distancia recorrida en la 6MWT entre el período basal y la visita de la semana 24 después del inicio del producto en investigación. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Patient global assessment (PGA) score at Weeks 6, 12, 24, 36 and 52. 2. Change in NYHA class at Weeks 6, 12, 24, 36 and 52. 3. Change in 6MWT distance from baseline to Weeks 6, 12, 36 and 52. 4. Change in fatigue score from baseline to Weeks 6, 12, 24, 36 and 52. 5. Change in Kansas City cardiomyopathy questionnaire (KCCQ) from baseline to Weeks 6, 12, 24, 36 and 52 (overall summary score and symptom frequency score). 6. Change in European quality of life 5D (EQ-5D) questionnaire total score from baseline to Weeks 6, 12, 24, 36 and 52. |
1. Puntuación en la evaluación global del paciente (PGA) en las semanas 6, 12, 24, 36 y 52. 2. Variación de la clase de la NYHA en las semanas 6, 12, 24, 36 y 52. 3. Variación de la distancia recorrida en la 6MWT entre el período basal y las semanas 6, 12, 36 y 52. 4. Variación de la puntuación de cansancio excesivo entre el período basal y las semanas 6, 12, 24, 36 y 52. 5. Variación del cuestionario de miocardiopatía de Kansas City (KCCQ) entre el período basal y las semanas 6, 12, 24, 36 y 52 (puntuación de resumen global y puntuación de frecuencia de síntomas). 6. Variación de la puntuación total en el cuestionario de calidad de vida europea 5D (EQ-5D) entre el período basal y las semanas 6, 12, 24, 36 y 52 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 6, 12, 24, 36, and 52 |
Semana 6, 12, 24, 36 y 52 |
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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 | No |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 34 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
France |
Germany |
Poland |
Russian Federation |
Spain |
Ukraine |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | Yes |
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
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last visit of last subject |
última visita del último paciente |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |