Maximising clinical applicability of non-invasive methods for optimisation of cardiac pacemakers and effect of optimisation on cardiac efficiency

ISRCTN	ISRCTN43384180
DOI	https://doi.org/10.1186/ISRCTN43384180
Protocol serial number	7354
Sponsor	Imperial College Healthcare NHS Trust (UK)
Funder	British Heart Foundation (BHF) (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Andreas Kyriacou
Scientific

St Mary's Hospital
International Centre for Circulatory Health
London
NW1 5QH
United Kingdom

Primary study design	Interventional
Study design	Non-randomised interventional and observational treatment validation of investigational/therapeutic process trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Maximising clinical applicability of non-invasive methods for optimisation of cardiac pacemakers and effect of optimisation on cardiac efficiency: a non-randomised interventional validation of investigational process trial
Study acronym	DRN 453 (BivPace Optimisation)
Study objectives	Assessment of atrioventricular (AV) optimisation on acute systolic blood pressure changes and the effect of this on cardiac efficiency at higher heart rates.
Ethics approval(s)	St Mary's REC, 01/10/2008, ref: 08/H0712/65
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease
Intervention	Optimisation of CRT devices: 1. Patients with existing devices are invited to attend for non-invasive haemodynamic optimisation 2. Patients are temporarily paced biventricularly at high heart rate and optimised using invasive and non-invasive haemodynamic parameters Study entry: registration only
Intervention type	Other
Primary outcome measure(s)	1. Acute improvement in systolic blood pressure 2. Cardiac efficiency Timepoints: End of first year and end of second year
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	01/04/2011

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	1. Chronic systolic heart failure and a biventricular device 2. In sinus rhythm (or atrially paced at rest) 3. Free of frequent ectopy 4. No aortic stenosis 5. Either sex, aged 40 - 90 years
Key exclusion criteria	1. Severe lung disease 2. Any condition that would preclude participants from lying comfortably on a couch for the duration of the study 3. No admissions, other than the admission related to the procedure for the invasive substudy in the prior month 4. No changes to medications (other than diuretic dose) in the prior month
Date of first enrolment	01/01/2009
Date of final enrolment	01/04/2011

St Mary's Hospital

London
NW1 5QH
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/05/2017: No publications found in PubMed, verifying study status with principal investigator