NCT00480051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2007

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

February 28, 2017

Status Verified

February 1, 2017

Enrollment Period

2.6 years

First QC Date

May 29, 2007

Last Update Submit

February 27, 2017

Conditions

Heart Failure, Congestive

Keywords

Cardiac FailurePacemakerDyssynchronyCardiac Magnetic ResonanceNarrow QRS

Outcome Measures

Primary Outcomes (1)

  • Improvements in 6-min walking distance

    6 months

Secondary Outcomes (3)

  • Symptomatic improvement in quality of life, using the Minnesota Living with Heart Failure questionnaire

    6 months

  • Change in NT pro-BNP and echocardiographic parameters of LV function

    6 months

  • Does MRI Dyssynchrony Index (CMR-TSI) predicts responders

    6 months

Interventions

Cardiac Resynchronization PacingDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sandwell Hospital

Birmingham, B71 4HJ, United Kingdom

Location

Good Hope Hospital

Sutton Coldfield, B75 7RR, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 21339317DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Pacing, ArtificialElectric Stimulation TherapyTherapeutics

Study Officials

  • Francisco Leyva, MD MB BS

    University of Birmingham

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

February 28, 2017

Record last verified: 2017-02

Locations

GB(2)