Contact information
Type
Scientific
Primary contact
Prof M Galinanes
ORCID ID
Contact details
University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom
+44 (0)116 258 4109
nicola.turner@uhl-tr.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0123138101
Study information
Scientific title
Haemodynamic performance and clinical outcome following aortic valve replacement
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular surgery
Intervention
Randomised controlled trial
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Haemodynamic performance and clinical outcome following aortic valve replacement
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2001
Overall trial end date
31/05/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Aortic valve replacement
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/06/2001
Recruitment end date
31/05/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospitals of Leicester
Leicester
LE1 4PW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospitals of Leicester NHS Trust (UK)
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