No registrations found.
ID
Source
Brief title
Health condition
Vasovagal syncope
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total burden of syncope recurrence.
Secondary outcome
1. Time to first recurrence syncope and presyncope;
2. Presyncope burden;
3. Quality of life.
Background 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.
Study objective
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.
Intervention
1. Physical Counterpressure Manoeuvres;
2. Midodrine.
Department of Internal Medicine,
P.O. Box 22660
W. Wieling
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
w.wieling@amc.uva.nl
Department of Internal Medicine,
P.O. Box 22660
W. Wieling
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5669111
w.wieling@amc.uva.nl
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;
9. Pregnancy;
10. Life expectancy < 1 year.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL112 |
| NTR-old | NTR143 |
| Other | : NHS 2003B156 |
| ISRCTN | ISRCTN29932893 |