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

ISRCTN	ISRCTN12205645
DOI	https://doi.org/10.1186/ISRCTN12205645
Protocol serial number	version 1
Sponsor	Good Hope Hospital NHS Trust (UK)
Funder	Application made to National Institute for Health Research Central Commissioning Facility (NIHR CCF) - Research for Patient Benefit (RfPB) programme (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Francisco Leyva
Scientific

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

Primary study design	Interventional
Study design	Non-blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy
Study objectives	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(s)	Review scheduled for the next committee date of the North Birmingham Ethics Committee.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Quality of Life using the Minnesota Living with Heart Failure questionnaire.
Completion date	30/03/2008

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	80
Key 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%
Key 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
Date of first enrolment	30/09/2006
Date of final enrolment	30/03/2008

Cardiology Department

Sutton Coldfield
B75 7RR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results:	01/07/2011		Yes	No

29/06/2016: Publication reference added