Condition category
Circulatory System
Date applied
17/08/2006
Date assigned
27/09/2006
Last edited
29/06/2016
Prospective/Retrospective
Prospectively 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 Francisco Leyva

ORCID ID

Contact details

Cardiology Department
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

version 1

Study information

Scientific title

A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy

Acronym

Study hypothesis

We hypothesise that the clinical benefits of cardiac resynchronisation therapy can be optimised by using impedance cardiography both at the time of biventricular pacemaker implantation and during follow up.

Ethics approval

Review scheduled for the next committee date of the North Birmingham Ethics Committee.

Study design

Non-blinded randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Heart failure

Intervention

A total of 80 patients will be recruited to the study:
1. Arm A: impedence cardiography - 40 patients will be assessed using Impedence Cardiography (ICG) to optimise treatment.
2. Arm B: standard cardiography - 40 patients will be assessed using the usual optimisation methods.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The primary objective is to assess whether the clinical benefits of cardiac resynchronisation therapy can be optimised using ICG both at the time of pacemaker implantation and during follow up. The primary endpoint is improvement in six minute walking distance.

Secondary outcome measures

Quality of Life using the Minnesota Living with Heart Failure questionnaire.

Overall trial start date

30/09/2006

Overall trial end date

30/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients who are referred to the cardiology clinic and meet the National Institute for Clinical Excellence (NICE) criteria for biventricular pacemaker implantation will be included in this study. The following inclusion criteria are:
1. Heart Failure
2. Moderate to severe function limitation New York Heart Association (NYHA) class III or IV, or NYHA class II heart failure plus a history of repeated admissions
3. Optimal tolerated treatment with diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, spironolactone and digoxin
4. QRS duration (representing the duration of ventricular depolarisation) more than or equal to 120 ms or evidence of mechanical Left Ventricular (LV) dyssynchrony
5. Left ventricular ejection fraction more than or equal to 40%

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

80 patients (40 to each arm)

Participant exclusion criteria

1. Contraindications to cardiac pacing
2. Presence of comorbidities likely to threaten survival within 12 months
3. Pulmonary oedema requiring intravenous diuretics in the previous week

Recruitment start date

30/09/2006

Recruitment end date

30/03/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiology Department
Sutton Coldfield
B75 7RR
United Kingdom

Sponsor information

Organisation

Good Hope Hospital NHS Trust (UK)

Sponsor details

Research Department
Trust HQ
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
-
dawn.richardson@goodhope.nhs.uk

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Application made to National Institute for Health Research Central Commissioning Facility (NIHR CCF) - Research for Patient Benefit (RfPB) programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2011 results: http://www.ncbi.nlm.nih.gov/pubmed/21339317

Publication citations

Additional files

Editorial Notes

29/06/2016: Publication reference added