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 |
| Protocol serial number | N0019189543 |
| Sponsor | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Funder | East Sussex Hospitals NHS Trust (UK), Peer Medical Research Trust |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled pilot study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | dobutamine |
| Primary outcome measure(s) |
Death, myocardial infarction, hospitalisation for CHF. |
| Key secondary outcome measure(s) |
1. Baseline tissue Doppler contractile reserve |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Eastbourne District General Hospital
Eastbourne
BN21 2UD
United Kingdom
BN21 2UD
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
