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
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
-
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.
-
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.