|- candidate number||1234|
|- NTR Number||NTR143|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||24-aug-2005|
|- Secondary IDs||NHS 2003B156 |
|- Public Title||Treatment strategy in patients with recurrent vasovagal syncope.|
|- Scientific Title||Treatment strategy in patients with recurrent vasovagal syncope.|
|- ACRONYM||STAND (Syncope Treatment Association Netherlands Danmark)|
|- hypothesis||1. In patients with recurrent vasovagal syncope, current conventional therapy will fail in 40%, after 1 year follow-up.|
2. In patients with recurrent vasovagal syncope, treated with conventional therapy and training in physical counterpressure manoeuvres, failure rate will be reduced to 20% (50% reduction) and Quality of Life will improve significantly.
3. In the subgroup of patients with recurrent vasovagal syncope, refractory to training in physical counterpressure manoeuvres, Midodrine therapy will lead to a recurrence rate of less than 20% and will improve Quality of Life significantly.
|- Healt Condition(s) or Problem(s) studied||Vasovagal syncope|
|- Inclusion criteria||1. Clinical diagnosis of classical neurally- mediated reflex syncope, based on the medical history ór non-classical diagnosis of neurally-mediated reflex syncope and a positive tilt-table test;|
2. 3 syncope episodes in the last 2 years;
3. Recognizable prodromal symptoms;
4. Age 18-70 years.
|- Exclusion criteria||1. Suspected or certain heart disease and high likelihood of cardiac syncope;|
2. Orthostatic hypotension;
3. Episodes of loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, TIA, intoxication, cataplexy);
4. Steal syndrome;
5. Psychologically or physically (due to any other illness) or cognitively unfit for participation in the study according to the opinion of the investigator;
6. Patient compliance doubtful;
7. Patient geographically or otherwise inaccessible for follow-up;
8. Patient unwilling or unable to give informed consent;
10. Life expectancy < 1 year.
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||2-jan-2005|
|- planned closingdate||2-jan-2008|
|- Target number of participants||300|
|- Interventions||1. Physical Counterpressure Manoeuvres;|
|- Primary outcome||Total burden of syncope recurrence.|
|- Secondary outcome||1. Time to first recurrence syncope and presyncope;|
2. Presyncope burden;
3. Quality of life.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. W. Wieling|
|- CONTACT for SCIENTIFIC QUERIES||Drs. N. Dijk, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Dutch Heart Foundation (Nederlandse Hartstichting)|
|- Brief summary||Patients with recurrent vasovagal syncope will be randomised between conventinal therapy alone of additional training in counterpressure manoeuvres. |
In case of recurrence a trial with midodrine (double nlind cross over) will be added to the therapy.
|- Main changes (audit trail)|
|- RECORD||17-aug-2005 - 14-dec-2006|