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Physical counterpressure manoeuvre trial.

Randomized Trial of optimal conventional therapy versus optimal conventional therapy plus counterpressure manoeuvres in patients with neurally-mediated syncope.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25436
Enrollment
200
Registered
2005-08-24
Start date
2003-01-05
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Vasovagal syncope.

Interventions

Physical counterpressure manoeuvres.

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactW. Wieling

Academic Medical Center (AMC), Department of Internal Medicine, P.O. Box 22660

w.wieling@amc.uva.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)