RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND)

ISRCTN	ISRCTN17623123
DOI	https://doi.org/10.1186/ISRCTN17623123
ClinicalTrials.gov (NCT)	NCT00480051
Protocol serial number	07/MRE00/57
Sponsor	Heart of England Foundation NHS Trust (UK)
Funder	Good Hope Hospital NHS Trust (UK) - Cardiology Clinical Research Fund

Submission date: 08/06/2007
Registration date: 12/09/2007
Last edited: 04/03/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francisco Leyva
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised open label active controlled parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	RESynchronisation in Patients with heart failure and a Normal QRS Duration (RESPOND): A randomised controlled trial
Study acronym	RESPOND
Study objectives	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(s)	Ethics approval received from the Scotland A Research Ethics Committee on the 15th June 2007 (ref: 3. 07/MRE00/57).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	60
Key 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 Simpsons methodology 5. Able to give informed consent
Key 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)
Date of first enrolment	01/07/2007
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Cardiology

Sutton Coldfield
B75 7RR
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2011		Yes	No