Condition category
Circulatory System
Date applied
08/06/2007
Date assigned
12/09/2007
Last edited
04/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francisco Leyva

ORCID ID

Contact details

Cardiology
Good Hope Hospital
Heart of England Foundation NHS Trust
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00480051

Protocol/serial number

07/MRE00/57

Study information

Scientific title

RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND): A randomised controlled trial

Acronym

RESPOND

Study hypothesis

Biventricular pacing in patients with heart failure and Quick Release System (QRS) less than 120 ms will improve patient exercise tolerance.

Please note that as of 19/02/10 the title and acronym of this study has been updated. The study was previously known as:
Title: Birmingham biventricular pacing in patients with heart failure unselected for dyssynchrony
Acronym: BIPIDS (BIventricular Pacing In patients unselected for DysSynchrony)

Ethics approval

Ethics approval received from the Scotland A Research Ethics Committee on the 15th June 2007 (ref: 3. 07/MRE00/57).

Study design

Randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Cardiac failure

Intervention

The patients will be randomised to the control and intervention groups (50% each). The patients in the intervention group will have the cardiac resynchronisation therapy (CRT) implant.

Please note that as of 19/02/10 data collection and enrollment for this trial has now ended.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Improvements in 6-minute walking distance (distance that the patient can walk at their own pace in 6 minutes) assessed at baseline, 6 weeks and 6 months. 20% increase in distance walked in 6 minutes, or any increase from 0 will be taken as a significant endpoint.

Secondary outcome measures

1. Symptomatic improvement in quality of life at baseline, 6 weeks after intervention and 6 monthly thereafter, assessed using the Minnesota Living with Heart Failure questionnaire
2. Change in N-terminal pro-beta natriuretic peptide (NT pro-BNP) and echocardiographic parameters of LV function at baseline, 6 weeks after intervention and 6 monthly thereafter. 15% decrease in end systolic volume will be taken as a significant endpoint
3. Assessing whether magnetic resonance imaging (MRI) Dyssynchrony Index (cardiovascular magnetic resonance tissue synchronisation imaging [CMR-TSI]) predicts responders (at baseline)
4. Packer outcome at 6 weeks after intervention and 6 monthly thereafter
5. Hospitalisation will be monitored at 6 weeks after intervention and 6 monthly thereafter
6. Mortality will be monitored at 6 weeks after intervention and 6 monthly thereafter

Overall trial start date

01/07/2007

Overall trial end date

01/07/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sinus rhythm
2. Symptomatic heart failure - New York Heart Association (NYHA) class III or IV
3. Electrocardiogram (ECG) QRS duration less than 120 milliseconds
4. Left ventricular (LV) ejection fraction of less than 35% on echocardiography using Simpson’s methodology
5. Able to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Age below 18
2. Current or planned pregnancy
3. Patient refusal
4. Ventricular tachycardia or ventricular fibrillation
5. Current or recent (within last 30 days) involvement in other studies
6. Requires implantable cardioverter defibrillator (ICD)

Recruitment start date

01/07/2007

Recruitment end date

01/07/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology
Sutton Coldfield
B75 7RR
United Kingdom

Sponsor information

Organisation

Heart of England Foundation NHS Trust (UK)

Sponsor details

Good Hope Hospital
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
+44 (0)121 378 2211
dawn.richardson@heartofengland.nhs.uk

Sponsor type

Government

Website

http://www.heartofengland.nhs.uk

Funders

Funder type

Government

Funder name

Good Hope Hospital NHS Trust (UK) - Cardiology Clinical Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21339317

Publication citations

  1. Results

    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, 97, 13, 1041-1047, doi: 10.1136/hrt.2010.208355.

Additional files

Editorial Notes