Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00480051
Protocol/serial number
07/MRE00/57
Study information
Scientific title
RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND): A randomised controlled trial
Acronym
RESPOND
Study hypothesis
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)
Ethics approval
Ethics approval received from the Scotland A Research Ethics Committee on the 15th June 2007 (ref: 3. 07/MRE00/57).
Study design
Randomised open label active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiac failure
Intervention
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.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
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.
Secondary outcome measures
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
Overall trial start date
01/07/2007
Overall trial end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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 Simpsons methodology
5. Able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
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)
Recruitment start date
01/07/2007
Recruitment end date
01/07/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cardiology
Sutton Coldfield
B75 7RR
United Kingdom
Sponsor information
Organisation
Heart of England Foundation NHS Trust (UK)
Sponsor details
Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
+44 (0)121 378 2211
dawn.richardson@heartofengland.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Good Hope Hospital NHS Trust (UK) - Cardiology Clinical Research Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21339317
Publication citations
-
Results
Foley PW, Patel K, Irwin N, Sanderson JE, Frenneaux MP, Smith RE, Stegemann B, Leyva F, Cardiac resynchronisation therapy in patients with heart failure and a normal QRS duration: the RESPOND study., Heart, 2011, 97, 13, 1041-1047, doi: 10.1136/hrt.2010.208355.