E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Drug-induced Long QT Syndrome |
Síndrome QT-Largo farmacológico |
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E.1.1.1 | Medical condition in easily understood language |
Long QT Syndrome that appears with certain pharmacological treatments |
Síndrome QT-Largo que aparece con medicamentos |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 |
-Identify the genetic alterations associated with drug-induced long QT syndrome in our environment. -To evaluate, in patients with drug-induced long QT syndrome, the response to the adrenaline test and its relationship with the genetic study |
-Identificar las alteraciones genéticas asociadas al SQTL farmacológico en nuestro entorno. -Evaluar, en pacientes con QT largo farmacológico, el tipo de respuesta al test de adrenalina y su relación con el estudio genético |
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E.2.2 | Secondary objectives of the trial |
-Compare the genetic alterations associated with drug-induced long QT syndrome in our environment with those documented in other populations. -To estimate the prevalence of drug-induced long QT syndrome in our environment. -Identify the drugs most commonly associated with drug-induced long QT syndrome in our environment. |
-Comparar las alteraciones genéticas asociadas al SQTL farmacológico en nuestro entorno con las documentadas en otras poblaciones. -Estimar la prevalencia del SQTL farmacológico en nuestro entorno. -Identificar los fármacos más comúnmente asociados a SQTL farmacológico en nuestro entorno. -Evaluar, en pacientes con QT largo farmacológico, el tipo de respuesta al test de adrenalina y su relación con el estudio genético |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients older than 18 years with a confirmed diagnosis of drug-induceded long QT syndrome who want to participate in the study and sign the informed consent. |
Pacientes mayores de 18 años con diagnóstico confirmado de SQTL farmacológico, que quieran participar en el estudio y firmen el consentimiento informado. |
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E.4 | Principal exclusion criteria |
-Patients under 18 years old -Patients of non-Caucasian ethnicity -Patients with a family history of congenital long QT syndrome -Patients with complete left bundle branch block, stimulated rhythms or non-sinus rhythms not related to SQTL -Patients with electrolyte abnormalities -Patients who do not sign informed consent |
-Menores de 18 años -Pacientes de etnia no caucásica -Pacientes con antecedentes familiares de QT largo congénito -Pacientes con bloqueo completo de rama izquierda, ritmos estimulados o ritmos no sinusales no relacionados con SQTL -Pacientes con alteraciones electrolíticas -Pacientes que no firmen el consentimiento informado |
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E.5 End points |
E.5.1 | Primary end point(s) |
Regarding the adrenaline test, the main endpoint will be the appearance of a paradoxical response of the QT interval in the electrocardiogram, defined as an extension of this interval> 30 ms with the adrenaline administration. |
En cuanto a la prueba de adrenalina, la variable principal de respuesta será la aparición de una respuesta paradójica del intervalo QT en el electrocardiograma, definida como una extensión de este intervalo> 30 ms con la administración de adrenalina. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The timepoint of this endopoint will be evaluated at the time of the adrenaline test, which will perfomed early after inclusion of the patient in the study. |
Se evaluará en el momento de la prueba de adrenalina, que se realizará después de la inclusión del paciente en el estudio. |
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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 | Yes |
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 | 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 | No |
E.8.1.1 | Randomised | No |
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 | No |
E.8.2.4 | Number of treatment arms in the trial | 120 |
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
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LVLS |
Última visita del último sujeto |
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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 | |
E.8.9.1 | In the Member State concerned days | |