Haemodynamic performance and clinical outcome following aortic valve replacement
| ISRCTN | ISRCTN78125390 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78125390 |
| Protocol serial number | N0123138101 |
| Sponsor | Department of Health |
| Funder | University Hospitals of Leicester NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 02/05/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Prof M Galinanes
Scientific
Scientific
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| nicola.turner@uhl-tr.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Haemodynamic performance and clinical outcome following aortic valve replacement |
| Study objectives | To investigate the influence of the surgical correction of aortic valve disease and of the type of prostheses used on: 1. The rate and extent of regression of myocardial hypertrophy 2. The recovery of normal cardiac function 3. The clinical outcome |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular surgery |
| Intervention | Randomised controlled trial |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Haemodynamic performance and clinical outcome following aortic valve replacement |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Aortic valve replacement |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 31/05/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
LE1 4PW
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 |
Editorial Notes
02/05/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.