Condition category
Circulatory System
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
14/10/2008
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 J J Bax

ORCID ID

Contact details

Leiden University Medical Centre (LUMC)
Department of Cardiology
P.O. Box 9600
Albinusdreef 2
Leiden
2300 RC
Netherlands
+31 (0)71 526 2020
j.j.bax@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR482

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Non-randomised, non-controlled, clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2003

Overall trial end date

01/05/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/05/2003

Recruitment end date

01/05/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (The Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/english/start_english.html

Funders

Funder type

Charity

Funder name

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

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

Publication citations

Additional files

Editorial Notes