| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN17623123 |
| Date ISRCTN assigned | 12/09/2007 |
| Local reference number(s) | 07/MRE00/57 |
| Public title | Birmingham biventricular pacing in patients with heart failure unselected for dyssynchrony |
| Scientific title |
|
| Acronym | BIPIDS (BIventricular Pacing In patients unselected for DysSynchrony) |
| Disease/condition/study domain | Cardiac failure |
| Study hypothesis | Biventricular pacing in patients with heart failure and QRS less than 120 ms will improve patient exercise tolerance. |
| Design/methodology | Randomised controlled trial. |
| Research ethics review | Scotland A Research Ethics Committee, approval pending as of 08/06/2007. |
| Countries of trial | United Kingdom |
| Participants - 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 Simpson¿s methodology
5. Able to give informed consent |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 01/07/2009 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | The patients will be randomized to the control and intervention groups (50% each). The patients in the intervention group will have the Cardiac Resynchronization Therapy (CRT) implanted. |
| Primary outcome measure(s) | Improvements in 6-min 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 measure(s) | 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-BNP (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 MRI Dyssynchrony Index (CMR-TSI) predicts responders (at baseline)
4. Packer outcome at 6 weeks after intervention and 6 monthly thereafter
5. Hospitalization 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 |
| Sources of funding | Good Hope Hospital NHS, Cardiolocy Clinical Research Fund (UK) |
| Sponsor name | Heart of England Foundation NHS Trust (UK) |
| Sponsor details | Good Hope Hospital
Rectory Road
Sutton Coldfield
United Kingdom
B75 7RR |
| Sponsor telephone | +121 378 2211 |
| Sponsor fax | + 121 311 1074 |
| Sponsor email | dawn.richardson@heartofengland.nhs.uk |
| Sponsor website | http://www.heartofengland.nhs.uk |
| Contact name | Dr Francisco Leyva |
| Contact details | Cardiology
Good Hope Hospital
Heart of England Foundation NHS Trust
Rectory Road
Sutton Coldfield
United Kingdom
B75 7RR |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN17623123 |
| Date last extracted from ISRCTN register | 17/04/2008 |
