Physical Counterpressure manoeuvre trial
| ISRCTN | ISRCTN45146526 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45146526 |
| Secondary identifying numbers | MEC 03/033; NTR138 |
- Submission date
- 06/12/2005
- Registration date
- 06/12/2005
- Last edited
- 10/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr W Wieling
Scientific
Scientific
Academic Medical Center
Department of Internal Medicine
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 566 9111 |
|---|---|
| w.wieling@amc.uva.nl |
Study information
| Study design | Randomised multi-centre, active controlled, parallel group, single blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised trial of optimal conventional therapy versus optimal conventional therapy plus counterpressure manoeuvres in patients with neurally-mediated syncope |
| Study acronym | PC-Trial |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Vasovagal syncope |
| Intervention | Physical counterpressure manoeuvres compared to standardised intensive conventional therapy. |
| Intervention type | Other |
| 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 study start date | 05/01/2003 |
| Completion date | 09/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2003 |
| Date of final enrolment | 09/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Center (AMC) (The Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Website | http://www.amc.uva.nl |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Charity
Netherlands Heart Foundation (Nederlandse Hartstichting) (The Netherlands) (ref: 2003B156)
No information available
Academic Medical Center (AMC) (The Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 17/10/2006 | Yes | No |
