Testosterone therapy as an adjunct to exercise rehabilitation: effects on exercise capacity, inflammatory markers and quality of life in hypogonadal males with chronic heart failure. - none
- Conditions
- Congestive heart failure
- Registration Number
- EUCTR2006-001090-23-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Symptoms of hypogonadism
Blood testosterone level of up to 15 nmol.l-1
Clinically stable CHF (longer than 6 months, prior to recruitment)
Evidence of impairment of left ventricular systolic function (defined by echocardiography as ejection fraction less than 35%)
Reduced exercise tolerance (limited by fatigue or breathlessness of cardiac origin)
Patients must be over 18 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Unstable angina
Recent acute myocardial infarction
Decompensated heart failure
Haemodynamically significant valvular heart disease
Uncontrolled hypertension
Renal insufficiency (serum creatinine >200umol/l)
Urologic disorders
Any orthopaedic or neurologic illness limiting the ability to exercise
Patients with prostate specific antigen (PSA) level above the age adjusted normal range will also be excluded
Patients taking sex hormone therapy
Patients with a peanut/soya allergy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method