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Heart Failure, CongestivePhase 3RESPONDNCT00480051

RESynchronisation in Patients With Heart Failure and a Normal QRS Duration

A Phase 3 study testing Cardiac Resynchronization Pacing in people with Heart Failure, Congestive, run by Heart of England NHS Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Congestive
What is being tested?
Cardiac Resynchronization Pacing
Type of treatment
Medical device
How many people
60 participants
Where
2 sitesUnited Kingdom
Study dates
Jul 2007to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Sandwell Hospital

    Birmingham, B71 4HJ

  • Good Hope Hospital

    Sutton Coldfield, B75 7RR

Other trials in United Kingdom

About this study

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.

Read the 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).

Being tested
Cardiac Resynchronization Pacing
Keywords
Cardiac Failure, Pacemaker, Dyssynchrony, Cardiac Magnetic Resonance, Narrow QRS
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac Resynchronization PacingDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Improvements in 6-min walking distance

    Measured: 6 months

Secondary outcomes (3)

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

    Measured: 6 months

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

    Measured: 6 months

  3. Does MRI Dyssynchrony Index (CMR-TSI) predicts responders

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480051
Sponsor's protocol ID
2007CD002.GH
Acronym
RESPOND
Status last verified
Feb 2017
First submitted
29 May 2007
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21339317

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cardiac Resynchronization Pacing in people with Heart Failure, Congestive, run by Heart of England NHS Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvements in 6-min walking distance (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480051, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.

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