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 |
| Secondary identifying numbers | 7354 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 11/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
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
Contact information
Dr Andreas Kyriacou
Scientific
Scientific
St Mary's Hospital
International Centre for Circulatory Health
London
NW1 5QH
United Kingdom
Study information
| Study design | Non-randomised interventional and observational treatment validation of investigational/therapeutic process trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 1. Acute improvement in systolic blood pressure 2. Cardiac efficiency Timepoints: End of first year and end of second year |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2009 |
| Completion date | 01/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned sample size: 50; UK sample size: 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Mary's Hospital
London
NW1 5QH
United Kingdom
NW1 5QH
United Kingdom
Sponsor information
Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
England
United Kingdom
| Website | http://www.imperial.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/056ffv270 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
11/05/2017: No publications found in PubMed, verifying study status with principal investigator
