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