Condition category
Circulatory System
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
01/09/2014
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 Andreas Kyriacou

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7354

Study information

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

Acronym

DRN 453 (BivPace Optimisation)

Study hypothesis

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

St Mary's REC, 01/10/2008, ref: 08/H0712/65

Study design

Non-randomised interventional and observational treatment validation of investigational/therapeutic process trial

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2009

Overall trial end date

01/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 50; UK sample size: 50

Participant 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

Recruitment start date

01/01/2009

Recruitment end date

01/04/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St Mary's Hospital
London
NW1 5QH
United Kingdom

Sponsor information

Organisation

Imperial College Healthcare NHS Trust (UK)

Sponsor details

International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.imperial.nhs.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

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

Publication citations

Additional files

Editorial Notes