Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
25/01/2010
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 SW Parry

ORCID ID

Contact details

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

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

government non-federal

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19919966

Publication citations

  1. 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.

Additional files

Editorial Notes