Home orthostatic training in vasovagal syncope (The HOT VVS-1 study): A placebo controlled trial

ISRCTN ISRCTN17688061
DOI https://doi.org/10.1186/ISRCTN17688061
Secondary identifying numbers N0503172648
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
25/01/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr SW Parry
Scientific

Department of Medicine
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Study information

Study designRandomised single-blind placebo controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymThe HOT VVS-1 study
Study objectivesAdded 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedVasovagal syncope
InterventionHome orthostatic training versus sham training in vasovagal syncope
Intervention typeOther
Primary outcome measureNumber of syncopal episodes in each patient group, which will assess the efficacy of orthostatic training.
Secondary outcome measures1. 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 study start date01/06/2005
Completion date31/05/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40 (20 in each arm of the study)
Key inclusion criteriaConsecutive patients aged 18+ diagnosed with head-up tilt positive vasovagal syncope.
Key exclusion criteria1. 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
Date of first enrolment01/06/2005
Date of final enrolment31/05/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Medicine
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Newcastle upon Tyne Hospitals NHS Trust (UK)
Government organisation / Local government
Alternative name(s)
Newcastle upon Tyne Hospitals NHS Trust
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2010 Yes No