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 |
| Protocol serial number | NTR482 |
| Sponsor | Leiden University Medical Centre (LUMC) (The Netherlands) |
| Funder | Netherlands Heart Foundation (Nederlandse Hartstichting) (NHS) (The Netherlands) |
- 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
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 |
|---|---|
| j.j.bax@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised, non-controlled, clinical trial |
| Secondary study design | Single-centre |
| 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(s) |
To develop non-invasive selection criteria (using echocardiography) to identify patients with end-stage heart failure who are likely to benefit from biventricular pacing. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
