Condition category
Signs and Symptoms
Date applied
06/12/2005
Date assigned
06/12/2005
Last edited
10/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://pctrial.free.fr

Contact information

Type

Scientific

Primary contact

Dr W Wieling

ORCID ID

Contact details

Academic Medical Center
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
+31 (0)20 566 9111
w.wieling@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MEC 03/033; NTR138

Study information

Scientific title

Randomised trial of optimal conventional therapy versus optimal conventional therapy plus counterpressure manoeuvres in patients with neurally-mediated syncope

Acronym

PC-Trial

Study hypothesis

In patients with syncope and absence of significant structural heart disease, physical counter pressure manoeuvres decrease the total syncope burden compared to standardized intensive conventional therapy.

Ethics approval

Not provided at time of registration

Study design

Randomised multi-centre, active controlled, parallel group, single blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Vasovagal syncope

Intervention

Physical counterpressure manoeuvres compared to standardised intensive conventional therapy.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Total burden of syncope recurrence (number of syncopal spells/year/patient).

Secondary outcome measures

1. Time to first recurrence
2. Presyncope burden
3. Quality of life

Overall trial start date

05/01/2003

Overall trial end date

09/01/2005

Reason abandoned

Eligibility

Participant 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 two years or at least one syncopal spell in the last year and at least three episodes of presyncope in the last year
3. Recognisable prodromal symptoms
4. Aged 16 - 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Suspected or certain heart disease and high likelihood of cardiac syncope:
1.1. Syncope preceded by palpitations or precordial pain
1.2. Syncope during exercise
1.3. Heart failure
1.4. Ejection fraction less than 40%
1.5. Old or recent myocardial infarction
1.6. Hypertrophic cardiomyopathy
1.7. Dilated cardiomyopathy
1.8. Significant valvular disease
1.9. Sinus bradycardia less than 50 bpm or sino-atrial blocks
1.10. Mobitz I second degree atrioventricular block
1.11. Mobitz II 2nd or 3rd degree atrioventricular block
1.12. Complete bundle branch block
1.13. Rapid paroxysmal supraventricular tachycardia or ventricular tachycardia
1.14. Pre-excited QRS complexes
1.15. Prolonged QT interval
1.16. Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada syndrome)
1.1.7. Negative T waves in right precordial leads, epsilon waves and ventricular late potentials suggestive of arrhythmogenic right ventricular dysplasia)
2. Orthostatic hypotension
3. Episodes of loss of consciousness different from syncope (e.g. epilepsy, psychiatric, metabolic, drop-attack, transient ischemic 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 one year

Recruitment start date

05/01/2003

Recruitment end date

09/01/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

University/education

Website

http://www.amc.uva.nl

Funders

Funder type

Charity

Funder name

Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands) (ref: 2003B156)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Academic Medical Center (AMC) (The Netherlands)

Alternative name(s)

Academic Medical Center, AMC

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/17045903

Publication citations

  1. Results

    van Dijk N, Quartieri F, Blanc JJ, Garcia-Civera R, Brignole M, Moya A, Wieling W, , Effectiveness of physical counterpressure maneuvers in preventing vasovagal syncope: the Physical Counterpressure Manoeuvres Trial (PC-Trial)., J. Am. Coll. Cardiol., 2006, 48, 8, 1652-1657, doi: 10.1016/j.jacc.2006.06.059.

Additional files

Editorial Notes