Condition category
Signs and Symptoms
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr W. Wieling

ORCID ID

Contact details

Academic Medical Centre
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 9111
w.wieling@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NHS 2003B156; NTR143

Study information

Scientific title

Acronym

STAND (Syncope Treatment Association Netherlands Danmark)

Study hypothesis

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

Received from the local medical ethics committee

Study design

Multicentre, randomised, single-blind, active controlled, crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Syncope recurrences during an entire treatment protocol including both physical counterpressure manoeuvres and the use of medication (midodrine)
2. The number of patients with recurrences during treatment with midodrine after recurrent failure of using the manoeuvres

Secondary outcome measures

1. Time to first recurrence syncope and presyncope
2. Presyncope burden
3. Quality of life

Overall trial start date

02/01/2005

Overall trial end date

02/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant 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

Recruitment start date

02/01/2005

Recruitment end date

02/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl/

Funders

Funder type

Research organisation

Funder name

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes