Condition category
Circulatory System
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Guy Lloyd

ORCID ID

Contact details

Cardiology Department
Eastbourne District General Hospital
Kings Drive
Eastbourne
BN21 2UD
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes