Condition category
Circulatory System
Date applied
21/08/2006
Date assigned
13/09/2006
Last edited
18/02/2013
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

Dr John Saxton

ORCID ID

Contact details

Centre for Sport and Exercise Science
Sheffield Hallam University
Collegiate Crescent Campus
Sheffield
S10 2BP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RG2511/06/07

Study information

Scientific title

Acronym

TEST-EX

Study hypothesis

Exercise rehabilitation and adjunctive testosterone therapy will evoke greater improvements in exercise capacity, circulating inflammatory markers, cardiac and skeletal muscle function, indices of psychological health status and quality of life than exercise alone in hypogonadal males with chronic heart failure.

Ethics approval

Ethics approval granted by the South Sheffield Research Ethics Committee (REC reference number: 06/Q2308/73), date of approval: June 2nd, 2006.

Study design

Randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Hypogonadal males with chronic heart failure

Intervention

Exercise alone versus exercise and adjunctive testosterone therapy.

Intervention type

Drug

Phase

Not Specified

Drug names

Testosterone

Primary outcome measures

Exercise capacity at the 12 week time point in relation to baseline.

Secondary outcome measures

1. Inflammatory markers
2. Tests of cardiac and skeletal muscle function
3. Indices of psychological health status
4. Quality of life

Overall trial start date

01/09/2006

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ambulant males
2. Over 18 years
3. Stable chronic heart failure
4. Blood testosterone level of less than 12 nmol/l
5. Symptoms of hypogonadism

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

36

Participant exclusion criteria

1. Unstable agina
2. Recent acute myocardial infarction
3. Decompensated heart failure
4. Haemodyamically significant valvular heart disease
5. Uncontrolled hypertension
6. Renal insufficiency
7. Urologic disorders
8. Orthopedic/neurologic illness limiting the ability to exercise

Recruitment start date

01/09/2006

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre for Sport and Exercise Science
Sheffield
S10 2BP
United Kingdom

Sponsor information

Organisation

Heart Research (UK)

Sponsor details

Suite 12D
Joseph's Well
Leeds
LS3 1AB
United Kingdom

Sponsor type

Charity

Website

http://www.heartresearch.org.uk

Funders

Funder type

Not defined

Funder name

Heart Research (UK) (reference number: RG2511/06/07)

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

1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17137495
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23194490

Publication citations

  1. Protocol

    Saxton JM, Zwierska I, Mathur A, Channer KS, Study protocol to investigate the effects of testosterone therapy as an adjunct to exercise rehabilitation in hypogonadal males with chronic heart failure., BMC Cardiovasc Disord, 2006, 6, 46, doi: 10.1186/1471-2261-6-46.

  2. Results

    Stout M, Tew GA, Doll H, Zwierska I, Woodroofe N, Channer KS, Saxton JM, Testosterone therapy during exercise rehabilitation in male patients with chronic heart failure who have low testosterone status: a double-blind randomized controlled feasibility study., Am. Heart J., 2012, 164, 6, 893-901, doi: 10.1016/j.ahj.2012.09.016.

Additional files

Editorial Notes