Clinical trial NCT00480051: RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Official title: RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure, Congestive
Keywords: Cardiac Failure
Pacemaker
Dyssynchrony
Cardiac Magnetic Resonance
Narrow QRS
Lead sponsor: Heart of England NHS Trust
Sponsor class: OTHER
Collaborators: name: Sandwell & West Birmingham Hospitals NHS Trust
First posted: 2007-05-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Improvements in 6-min walking distance
timeFrame: 6 months
Secondary outcomes:
measure: Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire
timeFrame: 6 months
measure: Change in NT pro-BNP and echocardiographic parameters of LV function
timeFrame: 6 months
measure: Does MRI Dyssynchrony Index (CMR-TSI) predicts responders
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Sandwell Hospital
city: Sutton Coldfield
country: United Kingdom
facility: Good Hope Hospital
Study officials:
affiliation: University of Birmingham
name: Francisco Leyva, MD MB BS
role: STUDY_CHAIR
affiliation: Heart of England NHS Foundation Trust
name: Paul W Foley, MB ChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Sandwell & West Birmingham Hospitals NHS Trust
name: Kiran Patel, PhD MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Bakken Research Centre, The Netherlands
name: Berthold Stegemann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Birmingham
name: Russell EA Smith, FRCP MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foley PW, Patel K, Irwin N, Sanderson JE, Frenneaux MP, Smith RE, Stegemann B, Leyva F. Cardiac resynchronisation therapy in patients with heart failure and a normal QRS duration: the RESPOND study. Heart. 2011 Jul;97(13):1041-7. doi: 10.1136/hrt.2010.208355. Epub 2011 Feb 21.