A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy
| ISRCTN | ISRCTN12205645 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12205645 |
| Secondary identifying numbers | version 1 |
- Submission date
- 17/08/2006
- Registration date
- 27/09/2006
- Last edited
- 29/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Francisco Leyva
Scientific
Scientific
Cardiology Department
Good Hope Hospital NHS Trust
Rectory Road
Sutton Coldfield
B75 7RR
United Kingdom
Study information
| Study design | Non-blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A randomised study on use of impedance cardiography for optimisation of cardiac resynchronisation therapy |
| Study objectives | We hypothesise that the clinical benefits of cardiac resynchronisation therapy can be optimised by using impedance cardiography both at the time of biventricular pacemaker implantation and during follow up. |
| Ethics approval(s) | Review scheduled for the next committee date of the North Birmingham Ethics Committee. |
| Health condition(s) or problem(s) studied | Heart failure |
| Intervention | A total of 80 patients will be recruited to the study: 1. Arm A: impedence cardiography - 40 patients will be assessed using Impedence Cardiography (ICG) to optimise treatment. 2. Arm B: standard cardiography - 40 patients will be assessed using the usual optimisation methods. |
| Intervention type | Other |
| Primary outcome measure | The primary objective is to assess whether the clinical benefits of cardiac resynchronisation therapy can be optimised using ICG both at the time of pacemaker implantation and during follow up. The primary endpoint is improvement in six minute walking distance. |
| Secondary outcome measures | Quality of Life using the Minnesota Living with Heart Failure questionnaire. |
| Overall study start date | 30/09/2006 |
| Completion date | 30/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 80 patients (40 to each arm) |
| Key inclusion criteria | 80 patients who are referred to the cardiology clinic and meet the National Institute for Clinical Excellence (NICE) criteria for biventricular pacemaker implantation will be included in this study. The following inclusion criteria are: 1. Heart Failure 2. Moderate to severe function limitation New York Heart Association (NYHA) class III or IV, or NYHA class II heart failure plus a history of repeated admissions 3. Optimal tolerated treatment with diuretics, angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, spironolactone and digoxin 4. QRS duration (representing the duration of ventricular depolarisation) more than or equal to 120 ms or evidence of mechanical Left Ventricular (LV) dyssynchrony 5. Left ventricular ejection fraction more than or equal to 40% |
| Key exclusion criteria | 1. Contraindications to cardiac pacing 2. Presence of comorbidities likely to threaten survival within 12 months 3. Pulmonary oedema requiring intravenous diuretics in the previous week |
| Date of first enrolment | 30/09/2006 |
| Date of final enrolment | 30/03/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cardiology Department
Sutton Coldfield
B75 7RR
United Kingdom
B75 7RR
United Kingdom
Sponsor information
Good Hope Hospital NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Research Department
Trust HQ
Rectory Road
Sutton Coldfield
B75 7RR
England
United Kingdom
| dawn.richardson@goodhope.nhs.uk | |
"ROR" |
https://ror.org/015hfw664 |
Funders
Funder type
Government
Application made to National Institute for Health Research Central Commissioning Facility (NIHR CCF) - Research for Patient Benefit (RfPB) programme (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results: | 01/07/2011 | Yes | No |
Editorial Notes
29/06/2016: Publication reference added
