RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

NCT ID: NCT00480051

Last Updated: 2017-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2010-02-28

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).

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Cardiac Resynchronization Pacing

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandwell & West Birmingham Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Heart of England NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco Leyva, MD MB BS

Role: STUDY_CHAIR

University of Birmingham

Paul W Foley, MB ChB MRCP

Role: PRINCIPAL_INVESTIGATOR

Heart of England NHS Foundation Trust

Kiran Patel, PhD MRCP

Role: PRINCIPAL_INVESTIGATOR

Sandwell & West Birmingham Hospitals NHS Trust

Berthold Stegemann, PhD

Role: PRINCIPAL_INVESTIGATOR

Bakken Research Centre, The Netherlands

Russell EA Smith, FRCP MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Birmingham

Locations

Sandwell Hospital

Birmingham, , United Kingdom

Good Hope Hospital

Sutton Coldfield, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 21339317 (View on PubMed)

Other Identifiers

2007CD002.GH

Identifier Type: -

Identifier Source: org_study_id