Treatment strategy in patients with recurrent vasovagal syncope

ISRCTN	ISRCTN29932893
DOI	https://doi.org/10.1186/ISRCTN29932893
Secondary identifying numbers	NHS 2003B156; NTR143

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

Academic Medical Centre
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands

Phone	+31 (0)20 566 9111
Email	w.wieling@amc.uva.nl

Study information

Study design	Multicentre, randomised, single-blind, active controlled, crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	02/01/2005
Completion date	02/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan