Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
TARgeted left ventricular lead placement to Guide cardiac rEsynchronisation Therapy in patients with heart failure: a randomised prospective study (TARGET Study)
Acronym
TARGET Study
Study hypothesis
The clinical response to cardiac resynchronisation therapy will be improved by optimising the site of left ventricular (LV) pacing using a targeted approach to optimal sites defined by pre-implant speckle tracking 2D radial strain as the latest contracting segments.
Ethics approval
Hertfordshire Research Ethics Committee approved on the 14th October 2008 (ref: 08/H0311/133)
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Cardiovascualr disease/heart failure/device therapy
Intervention
All patients schedules for CRT who are suitable candidates are randomised into one of two groups. All patients have baseline tests to include echocardiography, NYHA class assessment, 6-minute walk test, QoL score and speckle training echocardiography (STE). At implant, the control group has a usual implant and the target group has the devide implanted using echo guidance. All patients are followed up again at 6 months with a repeat of the baseline tests.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Response to treatment defined as greater than 15% reduction in Left Ventricular End Systolic Volume at 6 months follow up
Secondary outcome measures
Clinical Improvement in combined endpoint of 6 minute walk test performance, Minnesota Living with Heart Failure Questionnaire and NYHA Class
Overall trial start date
01/04/2009
Overall trial end date
01/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients (aged 18 years or older, either sex) limited by symptoms of heart failure (New York Heart Association Class III - IV)
2. Left ventricular ejection fraction (LVEF) of less than or equal to 35% and QRS width of greater than or equal to 120 ms despite maximally tolerated doses of standard heart failure treatment (diuretics, angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers, beta blockers and aldosterone antagonists)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
220 (110 in each arm)
Participant exclusion criteria
1. Limiting angina
2. Myocardial infarction within preceding 3 months
3. Significant LV hypertrophy
4. Severe co-morbid illness
Recruitment start date
01/04/2009
Recruitment end date
01/10/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Level 6 ACCI Building
Cambridge
CB2 2QQ
United Kingdom
Sponsor information
Organisation
Papworth Hospital NHS Foundation Trust (UK)
Sponsor details
R&D Department
Papworth Hospital
Cambridge
CB23 8RE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Research council
Funder name
Biomedical Research Council (BMRC) (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
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22405632
Publication citations
-
Results
Khan FZ, Virdee MS, Palmer CR, Pugh PJ, O'Halloran D, Elsik M, Read PA, Begley D, Fynn SP, Dutka DP, Targeted left ventricular lead placement to guide cardiac resynchronization therapy: the TARGET study: a randomized, controlled trial., J. Am. Coll. Cardiol., 2012, 59, 17, 1509-1518, doi: 10.1016/j.jacc.2011.12.030.