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Physical counterpressure manoeuvre trial.


- candidate number1229
- NTR NumberNTR138
- ISRCTNISRCTN45146526
- Date ISRCTN created6-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR24-aug-2005
- Secondary IDsMEC 03/033 
- Public TitlePhysical counterpressure manoeuvre trial.
- Scientific TitleRandomized Trial of optimal conventional therapy versus optimal conventional therapy plus counterpressure manoeuvres in patients with neurally-mediated syncope.
- ACRONYMPC-Trial
- hypothesisIn patients with syncope and and absence of significant structural heart disease physical counterpressure manoeuvres decrease the total syncope burden compared to standardized intensive conventional therapy.
- Healt Condition(s) or Problem(s) studiedVasovagal syncope
- Inclusion criteria1. Clinical diagnosis of classical neurally-mediated reflex syncope, based on the medical history ór non-classical diagnosis of neurally-mediated reflex syncope and a positive tilt-table test.
2. 3 syncope episodes in the last 2 years ór at least 1 syncopal spell in the last year and at least 3 episodes of presyncope in the last year;
3. Recognizable prodromal symptoms;
4. Age 16-70 years.
- Exclusion criteria1. Suspected or certain heart disease and high likelihood of cardiac syncope:
a. Syncope preceded by palpitations or precordial pain;
b. Syncope during exercise;
c. Heart failure;
d. Ejection fraction < 40%;
e. Old or recent myocardial infarction;
f. Hypertrophic cardiomyopathy;
g. Dilated cardiomyopathy;
h. Significant valvular disease;
i. Sinus bradycardia < 50 bpm or sino-atrial blocks;
j. Mobitz I second degree atrioventricular block;
k. Mobitz II 2nd or 3rd degree atrioventricular block;
l. Complete bundle branch block;
m. Rapid paroxysmal supraventricular tachycardia or ventricular tachycardia;
n. Pre-excited QRS complexes;
o. Prolonged QT interval;
p. Right bundle branch block pattern with ST-elevation in leads V1-V3 (Brugada syndrome);
q. 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, 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 < 1 year.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 5-jan-2003
- planned closingdate9-jan-2005
- Target number of participants200
- InterventionsPhysical counterpressure manoeuvres.
- Primary outcomeTotal burden of syncope recurrence (number of syncopal spells/year/patient).
- Secondary outcome1. Time to first recurrence;
2. Presyncope burden;
3. Quality of life.
- TimepointsN/A
- Trial web sitehttp://pctrial.free.fr
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. W. Wieling
- CONTACT for SCIENTIFIC QUERIESDrs. N. Dijk, van
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Dutch Heart Foundation (Nederlandse Hartstichting)
- Publications1. J Am Coll Cardiol. 2006 Oct 17;48(8):1652-7. Epub 2006 Sep 26.
- Brief summaryPhysical counterpressure-manoeuvres have been reported as effective on controlling or aborting neurally mediated syncope.
In this trial we will study the long-term effects of these manoeuvres by randomising patients between conventional therapy or additional training in manoeuvres.
- Main changes (audit trail)
- RECORD17-aug-2005 - 23-jun-2008


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