Condition category
Circulatory System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
01/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Andrew Clark

ORCID ID

Contact details

Department of Cardiology
Castle Hill Hospital
Castle Road
Cottingham
East Yorkshire
HU16 5JQ
United Kingdom
+44 (0)1482 875 875
A.L.Clark@hull.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084089156

Study information

Scientific title

Acronym

Study hypothesis

Is thalidomide a benefit to patients with chronic heart failure, specifically those with evidence of 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

Treatment

Patient information sheet

Condition

Cardiovascular: Heart failure

Intervention

Randomised controlled trial comparing a) thalidomide and b) placebo 100 mg twice daily for 12 weeks in random order. End points will be measured at baseline, crossover point and end of study.

Added 27/09/2013: this trial was stopped due to poor recruitment in 2004.

Intervention type

Drug

Phase

Not Applicable

Drug names

Thalidomide

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2000

Overall trial end date

01/12/2008

Reason abandoned

Participant recruitment issue

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

01/08/2000

Recruitment end date

01/12/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Cardiology
Cottingham, East Yorkshire
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Research organisation

Funder name

The North and South Bank Research and Development Consortium (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