E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
aortic stenosis |
estenosis aórtica |
|
E.1.1.1 | Medical condition in easily understood language |
Aortic stenosis is a disease that affects the aortic valve, narrowing the flow of blood. |
La estenosis aórtica es una enfermedad que afecta a la válvula aórtica, estrechando el paso de la sangre |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
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 evaluate the efficacy of glucocorticoids administered peri-procedure to prevent the appearance of conduction disturbances and the need for MCP implantation in patients undergoing TAVI. |
evaluar la eficacia de los glucocorticoides administrados peri-procedimiento para la prevención de la aparición de alteraciones de la conducción y la necesidad de implante de MCP en pacientes sometidos a TAVI. |
|
E.2.2 | Secondary objectives of the trial |
-To evaluate the effect of the administration of glucocorticoids on secondary variables such as hospital stay, rate of complications related to the procedure, mortality, inflammation parameters in the blood test, etc. -To assess the safety of glucocorticoid administration in patients undergoing TAVI. |
-Evaluar el efecto de la administración de glucocorticoides sobre variables secundarias como la estancia hospitalaria, tasa de complicaciones relacionadas con el procedimiento, mortalidad, parámetros de inflamación en la analítica de sangre…etc. -Evaluar la seguridad de la administración de glucocorticoides en pacientes sometidos a TAVI. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Candidate patients for TAVI implantation according to current clinical guidelines at the Dr. Balmis General University Hospital in Alicante. |
Pacientes candidatos a implante de TAVI según las guías clínicas actuales en el Hospital General Universitario Dr. Balmis de Alicante. |
|
E.4 | Principal exclusion criteria |
1. Patients with a previous pacemaker. 2. Patients with contraindications to the use of glucocorticoids: active infection, documented hypersensitivity or allergy, insulin-dependent diabetes mellitus, or acute heart failure. 3. Patients under previous chronic treatment with glucocorticoids. 4. Access for the TAVI implant other than the femoral one (for example: the transapical one). |
1. Pacientes portadores de un marcapasos previo. 2. Pacientes con contraindicación para el uso de glucocorticoides: infección activa, hipersensibilidad o alergia documentada, diabetes mellitus insulinodependiente o insuficiencia cardiaca (aguda. 3. Pacientes bajo tratamiento crónico previo con glucocorticoides. 4. Acceso para el implante de TAVI diferente al femoral (por ejemplo: el transapical). |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
|
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 | Yes |
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) | 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 | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
LOS PACIENTES SERÁN ALEATORIZADOS A RECIBIR O NO RECIBIR EL TRATAMIENTO DEL ESTUDIO |
PATIENTS WILL BE RANDOMIZED TO RECIEVE OR NOT RECIEVE STUDY MEDICATION |
|
E.8.2.4 | Number of treatment arms in the trial | 30 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
THE END OF THE STUDY WILL BE CONSIDERED WHEN THE LAST FOLLOW-UP VISIT OF THE LAST PATIENT IS CARRIED OUT. |
EL FIN DE ESTUDIO SE CONSIDERARA CUANDO SE REALICE LA ÚLTIMA VISITA DE SEGUIMIENTO 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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |