Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0019189543
Study information
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
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular: Mitral valve disease
Intervention
Dobutamine vs standard practice
Intervention type
Drug
Phase
Not Specified
Drug names
dobutamine
Primary outcome measures
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 trial start date
07/03/2007
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
15
Participant exclusion criteria
1. Inability to perform test
2. Hypersensitivity to dobutamine or SonoView
Recruitment start date
07/03/2007
Recruitment end date
01/05/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Eastbourne District General Hospital
Eastbourne
BN21 2UD
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Sussex Hospitals NHS Trust (UK), Peer Medical Research Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary