Pilot study to test the usefulness of contractile reserve during dobutamine and exercise echo to predict recovery after mitral valve repair mitral valve prolapse
| ISRCTN | ISRCTN06298974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06298974 |
| Secondary identifying numbers | N0019189543 |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 24/08/2015
- 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 Guy Lloyd
Scientific
Scientific
Cardiology Department
Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom
Study information
| Study design | Randomised controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pilot study to test the usefulness of contractile reserve during dobutamine and exercise echo to predict recovery after mitral valve repair mitral valve prolapse |
| Study objectives | To assess usefulness of contractile reserve during dobutamine and exercise echo to predict recovery after mitral valve repair for mitral valve prolapse. Whether contractile reserve judged by stress echocardiography, both pharmacological and exercise, can accurately predict post-operative exercise performance as judged by metabolic exercise performance following valve repair for mitral valve prolapse. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Mitral valve disease |
| Intervention | Dobutamine vs standard practice |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | dobutamine |
| Primary outcome measure | Death, myocardial infarction, hospitalisation for CHF. |
| Secondary outcome measures | 1. Baseline tissue Doppler contractile reserve 2. Baseline exercise test parameters 3. Neurohumoral markers 4. TOE and surgical parameters |
| Overall study start date | 07/03/2007 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 15 |
| Key inclusion criteria | 1. Patients admitted to Eastbourne District General Hospital for mitral valve repair 2. Accepted for repair of mitral valve prolapse on clinical grounds and high probability of repairable valve |
| Key exclusion criteria | 1. Inability to perform test 2. Hypersensitivity to dobutamine or SonoView |
| Date of first enrolment | 07/03/2007 |
| Date of final enrolment | 01/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Eastbourne District General Hospital
Eastbourne
BN21 2UD
United Kingdom
BN21 2UD
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
East Sussex Hospitals NHS Trust (UK), Peer Medical Research Trust
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 |
