E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Valve Disease |
Enfermedad de Válvular |
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E.1.1.1 | Medical condition in easily understood language |
Valve Disease |
Enfermedad Valvular |
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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 | 18.1 |
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 |
-To determine whether treatment with atorvastatin is effective in reducing the progression of aortic dilatation in patients with bicuspid aortic valve. |
-Determinar si el tratamiento con atorvastatina es eficaz en la reducción de la progresión de la dilatación aórtica en pacientes con válvula aórtica bicúspide. |
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E.2.2 | Secondary objectives of the trial |
-To Define whether atorvastatin treatment slows the progression of valvular degeneration (valvular calcification) - To Define whether treatment with atorvastatin reduces clinical events during 3 years of follow-up. |
-Definir si el tratamiento con atorvastatina enlentece la progresión de la degeneración valvular (calcificación valvular) -Definir si el tratamiento con atorvastatina reduce los eventos clínicos durante 3 años de seguimiento. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients ? 18 years with bicuspid aortic valve confirmed by TTE (in case of doubt the use of other imaging techniques require: TEE or CT to confirm the diagnosis). -Disfunción Valve only moderate: in case of aortic stenosis with average <20 mmHg gradient and in case of aortic insufficiency with contracta <5 vein or jet width <7. -Aortic valve not show more light spots of calcification transthoracic study. -Diámetros Level aortic ascending aorta (sinus of Valsalva or tubular ascending aorta) ? 21mm / m2 but not reach 50 mm. -To Written informed consent. |
-Pacientes ? 18 años con válvula aórtica bicúspide confirmado por ETT (en caso de dudas se requerirá el uso de otras técnicas de imagen: ETE o TC para confirmación del diagnóstico). -Disfunción valvular no más que moderada: en caso de estenosis aórtica con gradiente medio <20mmHg y en caso de insuficiencia aórtica con vena contracta < 5 o anchura del jet < 7. -Válvula aórtica que no muestre más que ligeros puntos de calcificación al estudio transtorácico. -Diámetros aórticos a nivel de aorta ascendente (Senos de Valsalva o aorta ascendente tubular) ? 21mm/m2 pero sin alcanzar los 50 mm. -Otorgar el consentimiento informado por escrito. |
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E.4 | Principal exclusion criteria |
- Patients <18 years - Patients with uncontrolled hypertension and a history or risk of diabetes mellitus - Patients who are treated with statins or other lipid-lowering drug or have it as indication for clinical practice guidelines. - History of heart surgery or any segment of the aorta - A history of aortic dissection and / or aortic coarctation - Functional Class III-IV - History or presence of hepatic impairment (serum transaminases> 2times the upper limit of normal by each laboratory), renal (creatinine clearance <30 ml / min or creatinine> 2.5mg / dl), myopathy myopathy or creatine kinase levels> 5 times the ULN, and other gastrointestinal diseases, hematologic, endocrine or any other situation which in the opinion of the researcher may affect the assessment of study treatment - Hypersensitivity or intolerance to any component of the study drug or to intravenous contrast used in the TC - Pregnancy, lactation or gestational desire during the test period. In all women of childbearing age, a result of negative gonadotropin be required in the pregnancy test for entry into the study. - Ongoing Participation in another clinical trial |
-Pacientes <18 años - Pacientes con hipertensión arterial no controlada y antecedentes o riesgo de diabetes mellitus. -Pacientes que reciben tratamiento con estatinas u otro fármaco hipolipemiante o tienen indicación para ello según guías de práctica clínica. -Antecedentes de cirugía cardiaca o en cualquier segmento de la aorta -Antecedentes de disección aórtica y/o coartación aórtica -Clase funcional III- IV -Antecedentes o presencia de insuficiencia hepática (transaminasas séricas >2veces el límite superior de la normalidad según cada laboratorio), renal (aclaramiento de creatinina <30ml/min o creatinina>2.5mg/ dl), miopatía miopatía o niveles de creatina quinasa > 5 veces el valor máximo de normalidad, u otras enfermedades gastrointestinal, hematológica, endocrina o cualquier otra situación que a criterio del investigador pueda afectar la evaluación del tratamiento en estudio -Hipersensibilidad, intolerancia o contraindicación a alguno de los componentes del fármaco en estudio o al contraste endovenoso utilizado en el TC -Embarazo, lactancia o deseo gestacional durante la duración del ensayo. En todas aquellas mujeres en edad fértil, se requerirá un resultado de gonadotropina negativa en la prueba de embarazo para su entrada en el estudio. -Participación en curso en otro ensayo clínico |
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E.5 End points |
E.5.1 | Primary end point(s) |
Determination of the progression of aortic dilatation of the ascending aorta by measuring the change in diameter of the ascending aorta by CT in three years follow-up. The change in aortic diameter is defined by most of the differences between the measurements taken at the level of the aortic root and ascending aorta at baseline and end of study. |
Determinación de la progresión de la dilatación aórtica en aorta ascendente mediante la medición del cambio del diámetro de la aorta ascendente por TC en 3 años de seguimiento. El cambio del diámetro aórtico se definirá por la mayor de las diferencias entre las medidas realizadas a nivel de la raíz aórtica y la aorta ascendente en el estudio basal y final. |
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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) |
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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 | Yes |
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) | Yes |
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.8.2.4 | 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 | 8 |
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
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Last patient`s last visit |
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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |