Birmingham Biventricular Pacing in Patients With Heart Failure Unselected for Dyssynchrony (BIPIDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by Heart of England NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sandwell & West Birmingham Hospitals NHS Trust
Information provided by:
Heart of England NHS Trust
ClinicalTrials.gov Identifier:
NCT00480051
First received: May 29, 2007
Last updated: July 9, 2007
Last verified: May 2007
  Purpose

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.


Condition Intervention Phase
Heart Failure, Congestive
Device: Cardiac Resynchronization Pacing
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Heart of England NHS Trust:

Primary Outcome Measures:
  • Improvements in 6-min walking distance [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: June 2010
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480051

Contacts
Contact: Francisco Leyva +44 121 378 6604

Locations
United Kingdom
Sandwell Hospital Not yet recruiting
Birmingham, United Kingdom, B71 4HJ
Contact: Kiran Patel, PhD MRCP    + 44 121 507 3827      
Principal Investigator: Kiran Patel, PhD MRCP         
Good Hope Hospital Recruiting
Sutton Coldfield, United Kingdom, B75 7RR
Contact: Paul W Foley, MB ChB MRCP    0121 378 6604    paul.foley@heartofengland.nhs.uk   
Contact: Nick Irwin, BSc    0121 378 6604    nick.irwin@heartofengland.nhs.uk   
Principal Investigator: Francisco Leyva         
Sponsors and Collaborators
Heart of England NHS Trust
Sandwell & West Birmingham Hospitals NHS Trust
Investigators
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
  More Information

No publications provided by Heart of England NHS Trust

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00480051     History of Changes
Other Study ID Numbers: 2007CD002.GH
Study First Received: May 29, 2007
Last Updated: July 9, 2007
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Heart of England NHS Trust:
Cardiac Failure
Pacemaker
Dyssynchrony
Cardiac Magnetic Resonance
Narrow QRS

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014