Contact information
Type
Scientific
Primary contact
Miss Beth Unsworth
ORCID ID
Contact details
ICCH Building
59 North Wharf Road
London
W2 1LA
United Kingdom
-
bunsworth77@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7353
Study information
Scientific title
Assessment of right ventricular function during and following cardiac surgery and evaluation of pericardial physiology in preserving right ventricular function
Acronym
DRN 372
Study hypothesis
This is an observational study looking at the effects of cardiac surgery in right ventricular (RV) function in those patients referred for routine coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) operations.
Ethics approval
Sub-Committee of the REC, 19/01/2007, ref: 06/Q0403/163
Study design
Single-centre observational case-controlled study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Diabetes Research Network; Subtopic: Both; Disease: Cardiovascular disease
Intervention
Observational study using echocardiography to look at the immediate effects of cardiac surgery in RV function in those patients referred for routine CABG and AVR operations. Pre-, peri- and post-operative data collection.
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Post-operative assessment of RV function; patients are last seen one month after surgery, but consented to return possibly at 6 months.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/05/2009
Overall trial end date
30/09/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with chronic systolic heart failure confirmed by transthoracic echo
2. Male and female, aged 51 - 91 years
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
Planned sample size: 100; UK sample size: 100
Participant exclusion criteria
1. Patients with severe lung disease
2. Any condition that would preclude them from lying comfortably on a couch for the duration of the study
Recruitment start date
01/05/2009
Recruitment end date
30/09/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Imperial College Healthcare NHS Trust
London
W2 1LA
United Kingdom
Sponsor information
Organisation
Imperial College Healthcare NHS Trust (UK)
Sponsor details
International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
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