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ISRCTN
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ISRCTN74789510
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ClinicalTrials.gov identifier
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Public title
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Non-invasive haemodynamics to probe physiology and echocardiographic dyssynchrony in chronic heart failure
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Scientific title
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Acronym
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DRN 374 (V3E)
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Serial number at source
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7356
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Study hypothesis
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Patients with heart failure and pre-existing cardiac resynchronisation therapy (biventricular pacemakers), will be recruited from the pacemaker and heart failure clinics of our institution. Patients will be positioned on the couch. Continuous blood pressure monitoring will be undertaken on a beat by beat basis using the Finapres® device, and electrocardiogram (ECG) recordings will be made simultaneously. Data analysis will occur off line after measurements have been taken.
Hypothesis 1:
The patient will have the pacemaker settings altered while undergoing simultaneous measurements of 3D echo and blood pressure monitoring. These will be taken for 10 consectutive beats before and after the change in the pacemaker setting. The AV delay will be kept constant throughout. Analysis of data will occur offline once measurements are acquired. We will identify wheteher stroke volume measured in this way provides a reliable method for measuring the best interventricular delay when compare to non-invaisive blood pressure.
Hypothesis 2:
We will identify the VV delays, (pacemaker settings), giving the smallest amount of intraventricular dyssynchrony, hence allowing the most coordinated contraction by: 2.1. 2-segment TDI echo
2.2. On 12-segment 3D model
2-segment dyssynchrony measurements will be taken using pulse wave Doppler from the septum and lateral wall. 12-segment dyssynchrony measurements will be taken from the septal, lateral, anteroseptal, posterior, anterior and inferior regions at two different levels. The average of 5 measurements for each setting will be used. After offline analysis, the patient will return on a subsequent visit for haemodynamic comparison of the two echocardiographically optimal VV delays, by performing multiple transitions between the two optima while recording non-invasive blood pressure.
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Lay summary
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Ethics approval
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MREC approved (ref: 08/H0708/5)
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Study design
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Non-randomised interventional process of care treatment trial
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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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Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease
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Participants - inclusion criteria
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1. Aged 18 years or above, either sex
2. Ejection fraction less than 40%
3. Biventricular pacemaker in situ
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Participants - exclusion criteria
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1. Poor lead position
2. Pure diastolic dysfunction in the absence of systolic dysfunction
3. Decompensated heart failure
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Anticipated start date
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01/12/2008
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Anticipated end date
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01/12/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Planned Sample Size: 60; UK Sample Size: 60
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Interventions
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Patients are recruited and pacemaker settings are changed. Echocardiographic measurements are taken multiple times at each setting and the optimal for each parameter identified.
Study entry: registration only
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Primary outcome measure(s)
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The optimal pacemaker setting from echo techniques is compared against our gold standard (BP).
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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British Heart Foundation (BHF) (UK)
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Trial website
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Publications
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Contact name
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Dr
Punam
Pabari
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Address
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59 North Wharf Road
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City/town
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London
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Zip/Postcode
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W2 1LA
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Country
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United Kingdom
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Sponsor
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Imperial College Healthcare NHS Trust (UK)
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Address
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International Centre for Circulatory Health
59 North Wharf Road
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City/town
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London
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Zip/Postcode
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W2 1LA
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Country
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United Kingdom
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Sponsor website:
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http://www.imperial.nhs.uk/
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Date applied
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29/04/2010
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Last edited
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29/04/2010
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Date ISRCTN assigned
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29/04/2010
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