E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Insuficiencia cardiaca crónica y disfunción ventricular izquierda / Chronic heart failure and left ventricular dysfunction |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007558 |
E.1.2 | Term | Cardiac failure chronic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049694 |
E.1.2 | Term | Left ventricular dysfunction |
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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 |
- Evaluación de los efectos sobre la función cardiaca y el NT-proBNP. / Evaluation of the effects on cardiac function and NT-proBNP. |
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E.2.2 | Secondary objectives of the trial |
- Evaluación del perfil de seguridad / Evaluation of the safety profile. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Hombres o mujeres de edad mayor o igual a 18 años y menor o igual a 75 años. - Insuficiencia cardiaca crónica sintomática desde al menos 6 meses antes de la selección, - Clase funcional II o III según la NYHA, - Cardiopatía isquémica o micardiopatía dilatada idiopática como causa principal de la ICC, - Disfunción ventricular izquierda sistólica evidenciada por una FEVI menor o igual 35 % en los 6 meses previos a la selección, -Tratado con beta-bloqueantes durante al menos los 3 meses previos a la selección, -Tratado con un IECA y/o un ARAII durante al menos los 3 meses previos a la selección, - Concentración plasmática de NT-proBNP> 400 pg/mL o concentración plasmática de BNP > 100 pg/mL
- Male or female patients superior or equal to 18 years and less or equal to 75 years. - Symptomatic chronic heart failure for at least 6 months before selection. - NYHA functional class II or III. - Ischemic disease or idiopathic dilated cardiomyopathy as main cause for CHF. - Left ventricular systolic dysfunction as evidenced by a LVEF less or equal to 35 % as measured within 6 months before selection. - Beta-blocker treatment for at least 3 months before selection. - ACE inhibitor and/or an ARB treatment for at least 3 months before selection. - NT-proBNP plasma concentration superior or equal to 400 pg/mL or BNP plasma concentration superior or equal to 100 pg/mL. |
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E.4 | Principal exclusion criteria |
-Situación inestable en las 4 semanas previas a la selección, -Infarto de miocardio, angina inestable o revascularización coronaria recientes (en los 3 meses previos a la selección) - Antecedentes de ictus o accidente isquémico cerebral transitorio en los 3 meses previos a la selección, - Estenosis aórtica o mitral severa, regurgitación aórtica o mitral severa, - Enfermedad congenita del corazón, - Cardiomiopatía obstructiva hipertrófica, - Enfermedad pericárdica,
- Bloqueo auriculo-ventricular de segundo o tercer grado, - Duración del intervalo QT corregido (fórmula de Bazett) > 450 ms, - Antecedentes familiares de sindrome de QT largo o sindrome de QT largo congénito, - Hipercalcemia o hipocalcemia (calcio total sérico< 2.1 mmol por litro o> 2.6 mmol por litro), - Creatinina sérica > 200 micromoles por litro (> 2.26 mg/dL), - Anemia significativa definida como hemoglobina en sangre inferior a 110 gramos por litro (en hombres) o inferior a 100 gramos por litro (en mujeres) -ALAT o ASAT > 3 veces el límite superior de los valores de normalidad,
- Unstable condition within the previous 4 weeks before selection. - Recent (less than 3 months before selection) myocardial infarction, unstable angina or coronary revascularisation. - History of stroke or cerebral transient ischemic attack within the previous 3 months before selection. - Severe aortic or mitral stenosis, severe aortic regurgitation, or severe mitral regurgitation. - Congenital heart disease. - Hypertrophic obstructive cardiomyopathy. - Pericardial disease. - Atrio-ventricular block of second or third degree. - Corrected QT interval duration (Bazett?s formula) > 450 ms. - Family history of long QT syndrome or congenital long QT syndrome. - Serum creatinine > 200 micromoles/L (> 2.26 mg/dL). - ALAT or ASAT > 3 times the upper limit of normal values. - Serum total calcium < 2.1 mmol/L or > 2.6 mmol/L. - Blood hemoglobin lower than 110 g/L (in males) or lower than 100 g/L (in females). |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Parámetros ecocardiográficos /Echocardiographic parameters. - Concentración de NT-proBNP / NT-proBNP plasma concentrations. |
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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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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.8.3 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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 | Information not present in EudraCT |
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 |
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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
|
ültima visita del último paciente como se indica en el protocolo / Last Visit of Last Patient as stated in the protocol. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |