RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Study Overview
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Brief Summary
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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.

Detailed Description
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AIMS and Objectives A randomised controlled clinical trial Primary objective • 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. Randomisation: 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. This trial was known as the Birmingham biventricular pacing in patients unselected for dyssynchrony (BIPIDS).

Official Title
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RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

Conditions
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Heart Failure, Congestive

Intervention / Treatment
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* Device: Cardiac Resynchronization Pacing


Participation Criteria
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Eligibility Criteria
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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 echo 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Pacing|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in 6-min walking distance |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire |  | 6 months | 
| Change in NT pro-BNP and echocardiographic parameters of LV function |  | 6 months | 
| Does MRI Dyssynchrony Index (CMR-TSI) predicts responders |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac Failure, Pacemaker, Dyssynchrony, Cardiac Magnetic Resonance, Narrow QRS