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 measure
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 (if study stopped)
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
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
Universities (academic only)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/17045903
Publication citations
-
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.