Prediction of clinical improvement following biventricular pacing in patients with end-stage heart failure using tissue doppler echocardiography

ISRCTN	ISRCTN09353557
DOI	https://doi.org/10.1186/ISRCTN09353557
Secondary identifying numbers	NTR482

Submission date: 26/02/2007
Registration date: 26/02/2007
Last edited: 14/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J J Bax
Scientific

Leiden University Medical Centre (LUMC)
Department of Cardiology
P.O. Box 9600
Albinusdreef 2
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 2020
Email	j.j.bax@lumc.nl

Study information

Study design	Non-randomised, non-controlled, clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Screening
Scientific title
Study objectives	In patients with end-stage heart failure (New York Heart Association [NYHA] class III or IV, left ventricular ejection fraction [LVEF] less than 35%, QRS duration more than 120 ms, left bundle branch block [LBBB]), the dyssynchrony of the left ventricle is the most important predictor of clinical benefit. The dyssynchrony of the left ventricle can be assessed (at any time before implantation) non-invasively by tissue doppler imaging (TDI). Thus, information on dyssynchrony derived from TDI may predict clinical benefit from bi-ventricular pacing (BVP).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Heart disease, heart failure
Intervention	Patients will undergo BVP implantation based on traditional selection criteria. Maximal oxygen uptake (VO2 max) and TDI will be performed before and three months after BVP implantation. From these patients the TDI criteria which optimally predict clinical improvement (in VO2 max) will be derived.
Intervention type	Other
Primary outcome measure	To develop non-invasive selection criteria (using echocardiography) to identify patients with end-stage heart failure who are likely to benefit from biventricular pacing.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/05/2003
Completion date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	60
Key inclusion criteria	1. Severe heart failure (NYHA class III or IV) 2. Severely depressed LVEF less than 35% 3. QRS exhibiting left bundle branch block configuration with a duration greater than 120 ms
Key exclusion criteria	Does not comply with the above inclusion criteria
Date of first enrolment	01/05/2003
Date of final enrolment	01/05/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (The Netherlands)
Hospital/treatment centre

Department of Cardiology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/english/start_english.html
"ROR"	https://ror.org/027bh9e22

Funders

Funder type

Charity

Netherlands Heart Foundation (Nederlandse Hartstichting) (NHS) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan