Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480051
Status:
COMPLETED
Last Update Posted:
2017-02-28
First Post:
2007-05-29
Brief Title:
RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Sponsor:
Heart of England NHS Trust
Organization:
Heart of England NHS Trust
Study Overview
Official Title:
RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPOND
Brief Summary:
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
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:
AIMS and Objectives A randomised controlled clinical trial
Primary objective
Improvements in 6-min walking distance
Secondary objectives Determine
1 Symptomatic improvement in quality of life using the Minnesota Living with Heart Failure questionnaire
2 Change in NT pro-BNP and echocardiographic parameters of LV function
3 Does MRI Dyssynchrony Index CMR-TSI predicts responders
4 Morbidity and Mortality using CARE-HF definitions
5 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
Primary objective
Improvements in 6-min walking distance
Secondary objectives Determine
1 Symptomatic improvement in quality of life using the Minnesota Living with Heart Failure questionnaire
2 Change in NT pro-BNP and echocardiographic parameters of LV function
3 Does MRI Dyssynchrony Index CMR-TSI predicts responders
4 Morbidity and Mortality using CARE-HF definitions
5 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None