Condition category
Nutritional, Metabolic, Endocrine
Date applied
28/05/2010
Date assigned
01/10/2010
Last edited
30/09/2016
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

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

http://www.imperial.nhs.uk/

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

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.