Condition category
Circulatory System
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
03/09/2012
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 Philip A Poole-Wilson

ORCID ID

Contact details

Imperial College School of Medicine NHLI
Guy Scadding Building
Dovehouse Street
London
SW3 6LY
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201082084

Study information

Scientific title

Acronym

Study hypothesis

To investigate whether CHF is associated with immune dysregulation and to establish whether endotoxin levels are increased in heart failure patients and whether an endotoxin challenge is a component of immune activation in patients with severe CHF. Study could lead to new therapeutic insights and could contribute to the development of new therapeutic strategies for immune activation in CHF and a syndrome currently without effective treatment ie cardiac cachexia.

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

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Cardiovascular: Chronic heart failure

Intervention

Study A: Randomised Controlled Trial (10 cachetic and 10 non-cachetic stable CHF patients, and 10 controls)
Study B: Cohort Observation (10 CHF patients presenting acute oedematous exacerbation)

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/1997

Overall trial end date

29/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

20

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/1997

Recruitment end date

29/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College School of Medicine NHLI
London
SW3 6LY
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Royal Brompton and Harefield NHS Trust (UK) Joint Committee for Research

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