Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0503172648
Study information
Scientific title
Acronym
The HOT VVS-1 study
Study hypothesis
Added 19/11/09:
To detect possible autonomic changes due to home orthostatic training (HOT) and to assess the feasibility of a larger, placebo-controlled study of HOT in vasovagal syncope (VVS).
Ethics approval
Not provided at time of registration
Study design
Randomised single-blind placebo controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Vasovagal syncope
Intervention
Home orthostatic training versus sham training in vasovagal syncope
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Number of syncopal episodes in each patient group, which will assess the efficacy of orthostatic training.
Secondary outcome measures
1. Time to tilt-positivity
2. Time to first spontaneous syncope or pre-syncope (where this was the symptom at presentation)
3. Number of patients experiencing syncope or pre-syncope during follow-up
4. Frequency of symptoms
In addition, autonomic function tests will assess the mechanism by which orthostatic training works and improve the understanding of the mechanism behind vasovagal syncope.
The impact of orthostatic training will be assessed using quality of life measures.
Overall trial start date
01/06/2005
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Consecutive patients aged 18+ diagnosed with head-up tilt positive vasovagal syncope.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (20 in each arm of the study)
Participant exclusion criteria
1. Inability to give informed consent
2. Patients on drugs which can affect the autonomic nervous system which cannot be discontinued safely
3. Inability to stand for up to 40 minutes due to muscular or neurological disorders,
cardiac transplantation or pregnancy
Recruitment start date
01/06/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Medicine
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Newcastle upon Tyne Hospitals NHS Trust (UK)
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
United Kingdom
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
Basic results (scientific)
Publication list
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19919966
Publication citations
-
Results
Tan MP, Newton JL, Chadwick TJ, Gray JC, Nath S, Parry SW, Home orthostatic training in vasovagal syncope modifies autonomic tone: results of a randomized, placebo-controlled pilot study., Europace, 2010, 12, 2, 240-246, doi: 10.1093/europace/eup368.