Treatment strategy in patients with recurrent vasovagal syncope
| ISRCTN | ISRCTN29932893 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29932893 |
| Protocol serial number | NHS 2003B156; NTR143 |
| Sponsor | Academic Medical Centre (AMC) (Netherlands) |
| Funder | Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W. Wieling
Scientific
Scientific
Academic Medical Centre
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| w.wieling@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, single-blind, active controlled, crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | STAND (Syncope Treatment Association Netherlands Danmark) |
| Study objectives | 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 counter pressure 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 counter pressure manoeuvres, Midodrine therapy will lead to a recurrence rate of less than 20% and will improve quality of life significantly |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Vasovagal syncope |
| Intervention | 1. Physical counterpressure manoeuvres for all patients 2. Midodrine - crossover therapy Double-blind randomisation is used to decide whether patients first receive midodrine or placebo. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Syncope recurrences during an entire treatment protocol including both physical counterpressure manoeuvres and the use of medication (midodrine) |
| Key secondary outcome measure(s) |
1. Time to first recurrence syncope and presyncope |
| Completion date | 02/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. Clinical diagnosis of classical neurally-mediated reflex syncope, based on the medical history or non-classical diagnosis of neurally-mediated reflex syncope and a positive tilt-table test 2. Three syncope episodes in the last year 3. Recognisable prodromal symptoms 4. Aged 18 - 70 years |
| Key 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, transient ischaemic 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 less than 1 year |
| Date of first enrolment | 02/01/2005 |
| Date of final enrolment | 02/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
