Haemodynamic performance and clinical outcome following aortic valve replacement

ISRCTN	ISRCTN78125390
DOI	https://doi.org/10.1186/ISRCTN78125390
Secondary identifying numbers	N0123138101

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 02/05/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Prof M Galinanes
Scientific

University Hospitals of Leicester
c/o Research and Development Office
Leicester General Hospital NHS Trust
Leicester
LE1 4PW
United Kingdom

Phone	+44 (0)116 258 4109
Email	nicola.turner@uhl-tr.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Haemodynamic performance and clinical outcome following aortic valve replacement
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular surgery
Intervention	Randomised controlled trial
Intervention type	Procedure/Surgery
Primary outcome measure	Haemodynamic performance and clinical outcome following aortic valve replacement
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/06/2001
Completion date	31/05/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Aortic valve replacement
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/06/2001
Date of final enrolment	31/05/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospitals of Leicester

Leicester
LE1 4PW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

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

Funders

Funder type

Hospital/treatment centre

University Hospitals of Leicester NHS Trust (UK)

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

Editorial Notes

02/05/2018: No publications found, verifying study status with principal investigator.
04/03/2016: No publications found, verifying study status with principal investigator.