Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/03/2016
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

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

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

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

Publication citations

Additional files

Editorial Notes

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