Non-invasive haemodynamics to probe physiology and echocardiographic dyssynchrony in chronic heart failure
| ISRCTN | ISRCTN74789510 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74789510 |
| Protocol serial number | 7356 |
| Sponsor | Imperial College Healthcare NHS Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 11/08/2014
- 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 Punam Pabari
Scientific
Scientific
59 North Wharf Road
London
W2 1LA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional process of care treatment trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | |
| Study acronym | DRN 374 (V3E) |
| Study objectives | Patients with heart failure and pre-existing cardiac resynchronisation therapy (biventricular pacemakers) will be recruited from the pacemaker and heart failure clinics of our institution. Patients will be positioned on the couch. Continuous blood pressure monitoring will be undertaken on a beat by beat basis using the Finapres® device, and electrocardiogram (ECG) recordings will be made simultaneously. Data analysis will occur off line after measurements have been taken. Hypothesis 1: The patient will have the pacemaker settings altered while undergoing simultaneous measurements of 3D echo and blood pressure monitoring. These will be taken for 10 consecutive beats before and after the change in the pacemaker setting. The AV delay will be kept constant throughout. Analysis of data will occur offline once measurements are acquired. We will identify whether stroke volume measured in this way provides a reliable method for measuring the best interventricular delay when compared to non-invasive blood pressure. Hypothesis 2: We will identify the VV delays (pacemaker settings) giving the smallest amount of intraventricular dyssynchrony, hence allowing the most coordinated contraction by: 2.1. 2-segment TDI echo 2.2. On 12-segment 3D model 2-segment dyssynchrony measurements will be taken using pulse wave Doppler from the septum and lateral wall. 12-segment dyssynchrony measurements will be taken from the septal, lateral, anteroseptal, posterior, anterior and inferior regions at two different levels. The average of 5 measurements for each setting will be used. After offline analysis, the patient will return on a subsequent visit for haemodynamic comparison of the two echocardiographically optimal VV delays, by performing multiple transitions between the two optima while recording non-invasive blood pressure. |
| Ethics approval(s) | MREC approved, ref: 08/H0708/5 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease |
| Intervention | Patients are recruited and pacemaker settings are changed. Echocardiographic measurements are taken multiple times at each setting and the optimal for each parameter identified. Study entry: registration only |
| Intervention type | Other |
| Primary outcome measure(s) |
The optimal pacemaker setting from echo techniques is compared against our gold standard (BP). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Aged 18 years or above, either sex 2. Ejection fraction less than 40% 3. Biventricular pacemaker in situ |
| Key exclusion criteria | 1. Poor lead position 2. Pure diastolic dysfunction in the absence of systolic dysfunction 3. Decompensated heart failure |
| Date of first enrolment | 01/12/2008 |
| Date of final enrolment | 01/12/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
59 North Wharf Road
London
W2 1LA
United Kingdom
W2 1LA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
