| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Vasodepressive neuroreflex syncope |
| Sincope vasovagale di tipo vasodepressivo |
|
| E.1.1.1 | Medical condition in easily understood language |
| Transient loss of consciousness due to the activation of the vasovagal reflex which produces arterial hypotension |
| transitoria perdita di coscienza dovuta all’attivazione del riflesso vasovagale che agisce determinando ipotensione arteriosa |
|
| 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 | 16.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10042777 |
| E.1.2 | Term | Syncope vasovagal |
| E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10042772 |
| E.1.2 | Term | Syncope |
| E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 16.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10067550 |
| E.1.2 | Term | Neurally mediated syncope |
| E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
| 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 |
| The study is aimed to investigate the clinical effects (reduction in the number of syncope and symptoms associated with syncope) and instrumental (negativity of tilt testing and / or carotid sinus massage) resulting from the suspension / reduction of vasoactive drugs in patients with vasodepressor reflex syncope diagnosed by carotid sinus massage or tilt test. |
| Lo studio vuole investigare gli effetti clinici (riduzione del numero di sincopi e dei sintomi ad esse associati) e strumentali (negativizzazione dei risultati di tilt test e/o del massaggio del seno carotideo) derivanti dalla sospensione/riduzione di farmaci vasoattivi in pazienti affetti da sincope riflessa vasodepressiva diagnosticata mediante massaggio del seno carotideo o tilt test. |
|
| E.2.2 | Secondary objectives of the trial |
| Not applicable |
| Non applicabile |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| Patients on chronic therapy (> 1 year) with vasoactive drugs with recurrent reflex syncope (≥ 2 episodes / last year), for who it has been demonstrated positive tilt test or has been diagnosed with carotid sinus syndrome with predominantly vasodepressor component (form vasodepressor or mixed). |
| Pazienti in terapia cronica (>1 anno) con farmaci vasoattivi affetti da sincope riflessa ricorrente (≥2 episodi/ultimo anno), per i quali sia stata dimostrata positività del tilt test o sia stata diagnosticata sindrome del seno carotideo a prevalente componente vasodepressiva (forma vasodepressiva o mista). |
|
| E.4 | Principal exclusion criteria |
1 - Patients with a diagnosis of symptomatic orthostatic hypotension, defined as a reduction in systolic blood pressure greater than 20 mmHg or diastolic blood pressure greater than 10 mmHg during the first 3 minutes after orthostatism.
2 - Patients with a diagnosis of syncope different from the vasodepressor reflex syncope
3 - Patients with reflex syncope with negativity of both carotid sinus massage and tilt test
4 - Patients with a clinical diagnosis of reflex syncope with cardioinihibiting component that requires pacemaker implantation
5 - Patients with poorly controlled hypertension (> 150/95)
6 - Patients with heart failure in the suspension / reduction therapy carries the risk of worsening the heart failure
7 - Patients with cardiac arrhythmias in which the suspension / reduction of antiarrhythmic therapy carries the risk of worsening arrhythmias
8 - Patients with prior TIA or stroke. |
1- Pazienti con diagnosi di ipotensione ortostatica sintomatica, definita come riduzione della pressione sistolica maggiore di 20 mmHg o di quella diastolica maggiore di 10 mmHg durante i primi 3 minuti dall’assunzione dell’ortostatismo.
2- Pazienti con diagnosi di sincope di natura diversa dalla sincope riflessa vasodepressiva
3- Pazienti con sincope riflessa con negatività sia del massaggio del seno carotideo che del tilt test
4- Pazienti con diagnosi clinica di sincope riflessa con componente cardioinibitrice tale da richiedere impianto di pacemaker
5- Pazienti con ipertensione arteriosa mal controllata dalla terapia (>150/95)
6- Pazienti con scompenso cardiaco in cui la sospensione/riduzione della terapia comporta il rischio di aggravare lo scompenso
7- Pazienti con aritmie cardiache in cui la sospensione/riduzione della terapia antiaritmica comporta il rischio di aggravare le aritmie
8- Pazienti con pregresso TIA o stroke.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| Recurrence-free interval of syncope, syncope, stroke, fatal and nonfatal stroke. The range will be considered as the time between enrollment (the index event) and the date of onset of the first of the three events that represent the adverse event. The period of observation of patients in which the closure of the study will not occur adverse events, will be censored to the date of the last visit available. |
| Intervallo libero da recidiva di sincope, presincope , stroke fatale e stroke non fatale. L’intervallo sarà considerato come il tempo intercorrente tra l’arruolamento (l’evento indice) e la data di insorgenza del primo tra i tre eventi che rappresentano l’evento sfavorevole. Il tempo di osservazione dei pazienti in cui alla chiusura dello studio non si sarà verificato alcuni degli eventi sfavoreli, verrà troncato alla data dell’ultima visita clinica disponibile. |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
| E.5.2 | Secondary end point(s) |
1 - Recurrence-free interval of syncope. The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event .
2 - Recurrence-free interval of pre syncope . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event .
3 - Recurrence-free interval of fatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event .
4 - Recurrence-free interval of recurrent nonfatal stroke . The range will be considered as the time between enrollment ( the index event ) and the date of occurrence of the event that is the adverse event . |
1- Intervallo libero da recidiva di sincope. L’intervallo sarà considerato come il tempo intercorrente tra l’arruolamento (l’evento indice) e la data di insorgenza dell’evento che rappresenta l’evento sfavorevole. Il tempo di osservazione dei pazienti in cui alla chiusura dello studio non si sarà verificato alcuni degli eventi sfavoreli, verrà troncato alla data dell’ultima visita clinica disponibile.
2- Intervallo libero da recidiva di presincope. L’intervallo sarà considerato come il tempo intercorrente tra l’arruolamento (l’evento indice) e la data di insorgenza dell’evento che rappresenta l’evento sfavorevole. Il tempo di osservazione dei pazienti in cui alla chiusura dello studio non si sarà verificato alcuni degli eventi sfavoreli, verrà troncato alla data dell’ultima visita clinica disponibile.
3- Intervallo libero da recidiva di stroke fatale. L’intervallo sarà considerato come il tempo intercorrente tra l’arruolamento (l’evento indice) e la data di insorgenza dell’evento che rappresenta l’evento sfavorevole. Il tempo di osservazione dei pazienti in cui alla chiusura dello studio non si sarà verificato alcuni degli eventi sfavoreli, verrà troncato alla data dell’ultima visita clinica disponibile.
4- Intervallo libero da recidiva di stroke non fatale. L’intervallo sarà considerato come il tempo intercorrente tra l’arruolamento (l’evento indice) e la data di insorgenza dell’evento che rappresenta l’evento sfavorevole. Il tempo di osservazione dei pazienti in cui alla chiusura dello studio non si sarà verificato alcuni degli eventi sfavoreli, verrà troncato alla data dell’ultima visita clinica disponibile.
|
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
| 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 | 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) | 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 | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| 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 | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| Mantenimento della terapia vasoattiva con dosaggio pari a quello del momento della randomizzazione |
| No suspension/reduction of vasoactive drugs that patients take at the time of randomization |
|
| 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 | 3 |
| 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
|
| LVLS |
| ultima visita dell'ultimo paziente arruolato |
|
| 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 | |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
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