We hypothesize that leg crossing increases orthostatic tolerance of patients with recurrent orthostatically induced vasovagal syncope.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vasovagale reacties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Orthostatic tolerance
Secondary outcome
na
Background summary
Aiming for leg crossing as a prophylaxis for vasovagal reactions to occur *and
thus to upgrade its applicability from tertiary to secondary prevention, the
recent study entitled *Preventive leg crossing and objective orthostatic
tolerance* showed that in healthy volunteers (without recurrent vasovagal
syncopes) leg crossing improves orthostatic tolerance greatly. The study was
unable to show a beneficial effect of oral placebo on orthostatic tolerance.
Study objective
We hypothesize that leg crossing increases orthostatic tolerance of patients
with recurrent orthostatically induced vasovagal syncope.
Study design
In patients with recurrent orthostatic vasovagal syncope, a tilt table test
will be performed twice, with addition of *lower body negative
pressure* (LBNP). LBNP tilting is a reliable method of determining orthostatic
tolerance in healthy subjects with a high reproducibility. Orthostatic
tolerance will once be studied without intervention and once with leg crossing
as a permanent intervention.
Intervention
leg crossing (physical manoeuvre)
Study burden and risks
The risk in this study is that of an ongoing vasovagal syncope after
terminating the tilt protocol, possibly with temporary vagally mediated
bradycardia or asystole. Such asystolies are very rare in clinical routine tilt
tests (<0,5%) and self limiting. Fatalities during tilt tests have never been
reported.
Meibergdreef 9
1105AZ Amsterdam
Nederland
Meibergdreef 9
1105AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Age: 18-50 years;Inclusion criteria:
- Clinical diagnosis of classical vasovagal syncope, based on the history and possitive tilt test or
- Non-classical vasovagal syncope and a positive clinical tilt test. ;- *2 syncopic episodes in the last 2 years
Exclusion criteria
Exclusion criteria: ;- (suspected) pregnancy
- (suspected) cardiovascular disease, other than recurrent vasovagal syncope
- presence of any circumstance that is likely to interfere significantly with normal orthostatic tolerance and/or the use of LBNP and/or the use of leg crossing.
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 |
|---|---|
| CCMO | NL11877.018.06 |