Condition category
Circulatory System
Date applied
01/09/2010
Date assigned
08/02/2011
Last edited
19/06/2012
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 David Dutka

ORCID ID

Contact details

Level 6 ACCI Building
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

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 measures

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

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

http://www.papworthhospital.nhs.uk/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22405632

Publication citations

  1. 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.

Additional files

Editorial Notes