No registrations found.
ID
Source
Brief title
Health condition
Vasovagal syncope.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Total burden of syncope recurrence (number of syncopal spells/year/patient).
Secondary outcome
1. Time to first recurrence;
2. Presyncope burden;
3. Quality of life.
Background summary
Physical counterpressure-manoeuvres have been reported as effective on controlling or aborting neurally mediated syncope.
In this trial we will study the long-term effects of these manoeuvres by randomising patients between conventional therapy or additional training in manoeuvres.
Study objective
In patients with syncope and and absence of significant structural heart disease physical counterpressure manoeuvres decrease the total syncope burden compared to standardized intensive conventional therapy.
Study design
N/A
Intervention
Physical counterpressure manoeuvres.
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 ór at least 1 syncopal spell in the last year and at least 3 episodes of presyncope in the last year;
3. Recognizable prodromal symptoms;
4. Age 16-70 years.
Exclusion criteria
1. Suspected or certain heart disease and high likelihood of cardiac syncope:
a. Syncope preceded by palpitations or precordial pain;
b. Syncope during exercise;
c. Heart failure;
d. Ejection fraction < 40%;
e. Old or recent myocardial infarction;
f. Hypertrophic cardiomyopathy;
g. Dilated cardiomyopathy;
h. Significant valvular disease;
i. Sinus bradycardia < 50 bpm or sino-atrial blocks;
j. Mobitz I second degree atrioventricular block;
k. Mobitz II 2nd or 3rd degree atrioventricular block;
l. Complete bundle branch block;
m. Rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
n. Pre-excited QRS complexes;
o. Prolonged QT interval;
p. Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada syndrome);
q. Negative T waves in right precordial leads, epsilon waves and ventricular late potentials suggestive of arrhythmogenic right ventricular dysplasia).
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 | NL107 |
NTR-old | NTR138 |
Other | : MEC 03/033 |
ISRCTN | ISRCTN45146526 |