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RESynchronisation in Patients With Heart Failure and a Normal QRS Duration (RESPOND)

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ClinicalTrials.gov Identifier: NCT00480051
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : February 28, 2017
Sponsor:
Collaborator:
Sandwell & West Birmingham Hospitals NHS Trust
Information provided by (Responsible Party):
Heart of England NHS Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: Cardiac Resynchronization Pacing Phase 3

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: RESynchronisation in Patients With Heart Failure and a Normal QRS Duration
Study Start Date : July 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Improvements in 6-min walking distance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire [ Time Frame: 6 months ]
  2. Change in NT pro-BNP and echocardiographic parameters of LV function [ Time Frame: 6 months ]
  3. Does MRI Dyssynchrony Index (CMR-TSI) predicts responders [ Time Frame: 6 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00480051


Locations
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United Kingdom
Sandwell Hospital
Birmingham, United Kingdom, B71 4HJ
Good Hope Hospital
Sutton Coldfield, United Kingdom, B75 7RR
Sponsors and Collaborators
Heart of England NHS Trust
Sandwell & West Birmingham Hospitals NHS Trust
Investigators
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Study Chair: Francisco Leyva, MD MB BS University of Birmingham
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 University Hospital Birmingham
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Heart of England NHS Trust
ClinicalTrials.gov Identifier: NCT00480051    
Other Study ID Numbers: 2007CD002.GH
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Keywords provided by Heart of England NHS Trust:
Cardiac Failure
Pacemaker
Dyssynchrony
Cardiac Magnetic Resonance
Narrow QRS
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases