RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND)
| ISRCTN | ISRCTN17623123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17623123 |
| ClinicalTrials.gov number | NCT00480051 |
| Secondary identifying numbers | 07/MRE00/57 |
- Submission date
- 08/06/2007
- Registration date
- 12/09/2007
- Last edited
- 04/03/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francisco Leyva
Scientific
Scientific
Cardiology
Good Hope Hospital
Heart of England Foundation NHS Trust
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
Study information
| Study design | Randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND): A randomised controlled trial |
| Study acronym | RESPOND |
| Study objectives | 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(s) | Ethics approval received from the Scotland A Research Ethics Committee on the 15th June 2007 (ref: 3. 07/MRE00/57). |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/07/2007 |
| Completion date | 01/07/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/07/2007 |
| Date of final enrolment | 01/07/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiology
Sutton Coldfield
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Sponsor information
Heart of England Foundation NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
England
United Kingdom
| Phone | +44 (0)121 378 2211 |
|---|---|
| dawn.richardson@heartofengland.nhs.uk | |
| Website | http://www.heartofengland.nhs.uk |
Funders
Funder type
Government
Good Hope Hospital NHS Trust (UK) - Cardiology Clinical Research Fund
No information available
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 | 01/07/2011 | Yes | No |
