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Treatment strategy in patients with recurrent vasovagal syncope.


- candidate number1234
- NTR NumberNTR143
- ISRCTNISRCTN29932893
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsNHS 2003B156 
- Public TitleTreatment strategy in patients with recurrent vasovagal syncope.
- Scientific TitleTreatment strategy in patients with recurrent vasovagal syncope.
- ACRONYMSTAND (Syncope Treatment Association Netherlands Danmark)
- hypothesis1. 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) studiedVasovagal syncope
- Inclusion criteria1. 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 criteria1. 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;
9. Pregnancy;
10. Life expectancy < 1 year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type-
- Studytypeintervention
- planned startdate 2-jan-2005
- planned closingdate2-jan-2008
- Target number of participants300
- Interventions1. Physical Counterpressure Manoeuvres;
2. Midodrine.
- Primary outcomeTotal burden of syncope recurrence.
- Secondary outcome1. Time to first recurrence syncope and presyncope;
2. Presyncope burden;
3. Quality of life.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. W. Wieling
- CONTACT for SCIENTIFIC QUERIESDrs. N. Dijk, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summaryPatients 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)
- RECORD17-aug-2005 - 14-dec-2006


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