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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17688061
Enrollment
40
Registered
2006-09-29
Start date
2005-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasovagal syncope Circulatory System Syncope and collapse

Interventions

Home orthostatic training versus sham training in vasovagal syncope

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive patients aged 18+ diagnosed with head-up tilt positive vasovagal syncope.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Number of syncopal episodes in each patient group, which will assess the efficacy of orthostatic training.

Secondary

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026