Condition category
Circulatory System
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
11/08/2014
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 Punam Pabari

ORCID ID

Contact details

59 North Wharf Road
London
W2 1LA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7356

Study information

Scientific title

Acronym

DRN 374 (V3E)

Study hypothesis

Patients with heart failure and pre-existing cardiac resynchronisation therapy (biventricular pacemakers) will be recruited from the pacemaker and heart failure clinics of our institution. Patients will be positioned on the couch. Continuous blood pressure monitoring will be undertaken on a beat by beat basis using the FinapresĀ® device, and electrocardiogram (ECG) recordings will be made simultaneously. Data analysis will occur off line after measurements have been taken.

Hypothesis 1:
The patient will have the pacemaker settings altered while undergoing simultaneous measurements of 3D echo and blood pressure monitoring. These will be taken for 10 consecutive beats before and after the change in the pacemaker setting. The AV delay will be kept constant throughout. Analysis of data will occur offline once measurements are acquired. We will identify whether stroke volume measured in this way provides a reliable method for measuring the best interventricular delay when compared to non-invasive blood pressure.

Hypothesis 2:
We will identify the VV delays (pacemaker settings) giving the smallest amount of intraventricular dyssynchrony, hence allowing the most coordinated contraction by: 2.1. 2-segment TDI echo
2.2. On 12-segment 3D model

2-segment dyssynchrony measurements will be taken using pulse wave Doppler from the septum and lateral wall. 12-segment dyssynchrony measurements will be taken from the septal, lateral, anteroseptal, posterior, anterior and inferior regions at two different levels. The average of 5 measurements for each setting will be used. After offline analysis, the patient will return on a subsequent visit for haemodynamic comparison of the two echocardiographically optimal VV delays, by performing multiple transitions between the two optima while recording non-invasive blood pressure.

Ethics approval

MREC approved, ref: 08/H0708/5

Study design

Non-randomised interventional process of care treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease

Intervention

Patients are recruited and pacemaker settings are changed. Echocardiographic measurements are taken multiple times at each setting and the optimal for each parameter identified.

Study entry: registration only

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The optimal pacemaker setting from echo techniques is compared against our gold standard (BP).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/12/2008

Overall trial end date

01/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or above, either sex
2. Ejection fraction less than 40%
3. Biventricular pacemaker in situ

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 60; UK Sample Size: 60

Participant exclusion criteria

1. Poor lead position
2. Pure diastolic dysfunction in the absence of systolic dysfunction
3. Decompensated heart failure

Recruitment start date

01/12/2008

Recruitment end date

01/12/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

59 North Wharf Road
London
W2 1LA
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