Birmingham Biventricular Pacing in Patients With Heart Failure Unselected for Dyssynchrony (BIPIDS)
Recruitment status was: Recruiting
Patients who have heart failure and have electrical evidence of delay in the contraction of the left ventricle on an ECG tracing of the heart are eligible for biventricular pacing. Recent work has suggested that patients with heart failure who do not have electrical evidence of conduction delay (normal QRS) may benefit from biventricular pacing. The reliance on ECGs to determine the presence of dyssynchrony is widespread, although the ECG alone is not 100% sensitive and specific. ECG criteria for de-synchrony in heart failure patients are estimated to pick up only 30% of patients with dyssynchrony, and results in patients missing out on a potentially important treatment advance.
We would like to study patients with heart failure who have normal ventricular activation on their ECGs to see whether we can predict those patients who will respond to biventricular pacing.
Heart Failure, Congestive
Device: Cardiac Resynchronization Pacing
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Birmingham Biventricular Pacing in Patients With Heart Failure Unselected for Dyssynchrony (QRS < 120ms)- a Randomised Controlled Trial|
- Improvements in 6-min walking distance [ Time Frame: 6 months ]
- Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire [ Time Frame: 6 months ]
- Change in NT pro-BNP and echocardiographic parameters of LV function [ Time Frame: 6 months ]
- Does MRI Dyssynchrony Index (CMR-TSI) predicts responders [ Time Frame: 6 months ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||June 2010|
AIMS and Objectives A randomised controlled clinical trial
• Improvements in 6-min walking distance
Secondary objectives Determine
- Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
- Change in NT pro-BNP and echocardiographic parameters of LV function
- Does MRI Dyssynchrony Index (CMR-TSI) predicts responders.
- Morbidity and Mortality using CARE-HF definitions
- Packer combined clinical composite score
Study Design A pilot randomised controlled clinical trial 60 patients. The biventricular pacemaker with be optimized for both A-V delay and V-V delay.
Subject Selection Source – Patients attending Good Hope Hospital, Sandwell Hospital Centres involved – 2 Eligible Participants – 60 patients with heart failure and narrow QRS.
Inclusion Criteria Sinus rhythm Symptomatic heart failure – NYHA class III or IV ECG QRS duration less than 120 milliseconds LV ejection fraction of less than 35% on echocardiography using Simpsons technique.
Able to give informed consent
Exclusion Criteria Age below 18 Current or planned pregnancy Patient refusal Ventricular tachycardia or ventricular fibrillation Current or recent (within last 30 days) involvement in other studies Requires implantable cardioverter defibrillator (ICD) according to NICE criteria for implantation (England and Wales)
Definition of clinical response:- 20% improvement in 6 minute walk distance or any improvement from 0
Definition of echocardiographic response:- 15% or greater decrease in left ventricular end systolic volume
Follow up 6 weeks and 6 monthly thereafter. Interim results at 6 months. Analysis of results, echocardiograms, MRI and BNP will be blind Walk distance to be measured by unblinded observer and by pedometer.
Numbered envelopes will be prepared by sponsor (Heart of England NHS Foundation Trust) and kept from researchers. After informed consent, the patient will be enrolled and the technician will draw the result.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480051
|Birmingham, United Kingdom, B71 4HJ|
|Good Hope Hospital|
|Sutton Coldfield, United Kingdom, B75 7RR|
|Study Chair:||Francisco Leyva, MD MB BS||Heart of England NHS Foundation Trust|
|Principal Investigator:||Paul W Foley, MB ChB MRCP||Heart of England NHS Foundation Trust|
|Principal Investigator:||Kiran Patel, PhD MRCP||Sandwell & West Birmingham Hospitals NHS Trust|
|Principal Investigator:||Berthold Stegemann, PhD||Bakken Research Centre, The Netherlands|
|Principal Investigator:||Russell EA Smith, FRCP MD||Heart of England NHS Foundation Trust|