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ISRCTN
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ISRCTN67937027
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DOI
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10.1186/ISRCTN67937027
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Randomised Evaluation of Modified Valsalva Effectivness in Re-entrant Tachycardia (REVERT) study
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Scientific title
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Acronym
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REVERT
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Serial number at source
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13791
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Study hypothesis
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Supraventricular tachycardia (SVT) is a heart problem that causes the heart to beat very quickly, affecting thousands of people. Attacks are unpleasant but not usually dangerous. When patients come to hospital with SVT, they can help to get their heart beat back to normal by doing a ‘Valsalva Manoeuvre’ (VM). This is a strain while blowing, just like when trying to blow up a balloon. Often the VM does not work, however, and the patient is then usually given a strong medicine called adenosine. This has to be given into a vein and often makes people feel really unwell. Although this only lasts a few seconds, patients find it very unpleasant and some even say it makes them feel like they are about to die. Changing the way the VM is done might make it better at stopping the SVT. It is normally done with the person sitting (standard VM). If it's done in the same position but the person is laid down with their legs lifted at the end (modified VM), it might work better. We plan to do a trial to find out. In this trial, people with SVT who come to hospital (but are not too unwell) will be asked if they would like to take part. People who take part will be allocated at random to do either the standard or the modified VM and the doctors will then check if their hearts have gone back to normal with a heart tracing (ECG). After this, participants will be treated as usual with no more testing. If we find that one type of VM is more successful, we will let patients and doctors know which to use, to reduce the number of patients who need to have adenosine or other emergency treatments when they get this problem.
More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13791
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Lay summary
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Not provided at time of registration
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Ethics approval
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First MREC approval date 20/11/2012, ref: 12/SW/0281
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Study design
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Randomised; Interventional; Design type: Treatment
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Re-entrant Tachycardia
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Participants - inclusion criteria
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1. Age 18 years and over
2. Stable male or female adult patients presenting to the Emergency Department with SVT (regular, narrow complex tachycardia with QRS duration <0.12ms on ECG)
3. Written informed consent to participate
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Participants - exclusion criteria
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1. Unstable patient (BP < 90mmHg systolic or any indication for immediate drug or DC cardioversion)
2. Atrial fibrillation or atrial flutter on ECG
3. Suspected atrial flutter requiring a trial of adenosine
4. Severe hypertension (systolic BP >220mmHg or diastolic >120mmHg)
5. Any contraindication to or inability to performing a VM
6. Contraindication or inability to lay flat or lift legs
7. 3rd trimester pregnancy
8. Patients without capacity to provide written informed consent
9. Previous inclusion in the study
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Anticipated start date
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13/01/2013
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Anticipated end date
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01/09/2014
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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UK Sample Size: 372
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Interventions
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Control - Standard VM, Normal Valsalva strain at 40mmHg for 15 seconds in a semi-recumbent position, remaining in this position for 60 seconds after strain before reviewing ECG for cardioversion.
Intervention - Modified VM, Normal Valsalva strain at 40mmHg for 15 seconds in a semi-recumbent position, then lying participant flat and raising legs for 15 seconds before returning participant to semi-recumbent position for a further 45 seconds, before reviewing ECG for cardioversion.
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Primary outcome measure(s)
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The presence of sinus rhythm post Valsalva as determined by a 12 lead ECG.; Timepoint(s): 1 minute post-Valsalva
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Secondary outcome measure(s)
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1. Adverse events; Timepoint(s): From time of consent until discharge from emergency department (ED)
2. The need for hospital admission Timepoint(s): Post-Valsalva until discharge from ED.
3. Time spent in ED; Timepoint(s): From time of admission until discharge from ED.
4. Use of other emergency treatments for SVT in ED; Timepoint(s): Post-Valsalva until discharge from ED
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Sources of funding
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National Institute for Health Research (NIHR) - Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0211-24145
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Trial website
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Publications
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Contact name
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Ms
Jane
Vickery
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Address
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N14, I T T C Building
1 Tamar Science Park Davy Road
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City/town
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Plymouth
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Zip/Postcode
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PL6 8BX
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Country
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United Kingdom
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Email
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jane.vickery@pms.ac.uk
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Sponsor
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Royal Devon and Exeter Foundation Trust (UK)
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Address
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Royal Devon & Exeter Hospital
Barrack Road
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City/town
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Exeter
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Zip/Postcode
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EX2 5DW
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Country
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United Kingdom
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Sponsor website:
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http://www.rdehospital.nhs.uk/
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Date applied
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12/02/2013
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Last edited
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14/02/2013
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Date ISRCTN assigned
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14/02/2013
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