Immune activation in chronic heart failure and the role of endotoxin

ISRCTN	ISRCTN21486547
DOI	https://doi.org/10.1186/ISRCTN21486547
Secondary identifying numbers	N0201082084

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Philip A Poole-Wilson
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Immune activation in chronic heart failure and the role of endotoxin
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/1997
Completion date	29/06/2006

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	20
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/04/1997
Date of final enrolment	29/06/2006

Imperial College School of Medicine NHLI

London
SW3 6LY
United Kingdom

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Government

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

No information available

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	29/05/1999	28/02/2020	Yes	No

28/02/2020: Publication reference added.