Physical Counterpressure manoeuvre trial

Completed

• Conditions: Vasovagal syncope; Signs and Symptoms; Syncope

• Registration Number: ISRCTN45146526
• Lead Sponsor: Academic Medical Center (AMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Time to first recurrence<br>2. Presyncope burden<br>3. Quality of life