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ISRCTN
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ISRCTN17623123
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ClinicalTrials.gov identifier
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NCT00480051
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Public title
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RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND)
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Scientific title
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RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND): A randomised controlled trial
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Acronym
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RESPOND
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Serial number at source
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07/MRE00/57
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Study hypothesis
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Biventricular pacing in patients with heart failure and Quick Release System (QRS) less than 120 ms will improve patient exercise tolerance.
Please note that as of 19/02/10 the title and acronym of this study has been updated. The study was previously known as:
Title: Birmingham biventricular pacing in patients with heart failure unselected for dyssynchrony
Acronym: BIPIDS (BIventricular Pacing In patients unselected for DysSynchrony)
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Ethics approval
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Ethics approval received from the Scotland A Research Ethics Committee on the 15th June 2007 (ref: 3. 07/MRE00/57).
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Study design
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Randomised open label active controlled parallel group 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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Cardiac failure
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Participants - inclusion criteria
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1. Sinus rhythm
2. Symptomatic heart failure - New York Heart Association (NYHA) class III or IV
3. Electrocardiogram (ECG) QRS duration less than 120 milliseconds
4. Left ventricular (LV) ejection fraction of less than 35% on echocardiography using Simpson’s methodology
5. Able to give informed consent
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Participants - exclusion criteria
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1. Age below 18
2. Current or planned pregnancy
3. Patient refusal
4. Ventricular tachycardia or ventricular fibrillation
5. Current or recent (within last 30 days) involvement in other studies
6. Requires implantable cardioverter defibrillator (ICD)
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Anticipated start date
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01/07/2007
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Anticipated end date
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01/07/2009
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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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60
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Interventions
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The patients will be randomised to the control and intervention groups (50% each). The patients in the intervention group will have the cardiac resynchronisation therapy (CRT) implant.
Please note that as of 19/02/10 data collection and enrollment for this trial has now ended.
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Primary outcome measure(s)
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Improvements in 6-minute walking distance (distance that the patient can walk at their own pace in 6 minutes) assessed at baseline, 6 weeks and 6 months. 20% increase in distance walked in 6 minutes, or any increase from 0 will be taken as a significant endpoint.
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Secondary outcome measure(s)
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1. Symptomatic improvement in quality of life at baseline, 6 weeks after intervention and 6 monthly thereafter, assessed using the Minnesota Living with Heart Failure questionnaire
2. Change in N-terminal pro-beta natriuretic peptide (NT pro-BNP) and echocardiographic parameters of LV function at baseline, 6 weeks after intervention and 6 monthly thereafter. 15% decrease in end systolic volume will be taken as a significant endpoint
3. Assessing whether magnetic resonance imaging (MRI) Dyssynchrony Index (cardiovascular magnetic resonance tissue synchronisation imaging [CMR-TSI]) predicts responders (at baseline)
4. Packer outcome at 6 weeks after intervention and 6 monthly thereafter
5. Hospitalisation will be monitored at 6 weeks after intervention and 6 monthly thereafter
6. Mortality will be monitored at 6 weeks after intervention and 6 monthly thereafter
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Sources of funding
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Good Hope Hospital NHS Trust (UK) - Cardiology Clinical Research Fund
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Trial website
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Publications
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Contact name
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Dr
Francisco
Leyva
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Address
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Cardiology
Good Hope Hospital
Heart of England Foundation NHS Trust
Rectory Road
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City/town
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Sutton Coldfield
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Zip/Postcode
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B75 7RR
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Country
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United Kingdom
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Sponsor
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Heart of England Foundation NHS Trust (UK)
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Address
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Good Hope Hospital
Rectory Road
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City/town
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Sutton Coldfield
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Zip/Postcode
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B75 7RR
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Country
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United Kingdom
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Tel
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+44 (0)121 378 2211
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Fax
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+44 (0)121 311 1074
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Email
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dawn.richardson@heartofengland.nhs.uk
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Sponsor website:
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http://www.heartofengland.nhs.uk
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Date applied
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08/06/2007
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Last edited
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19/02/2010
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Date ISRCTN assigned
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12/09/2007
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