Congestive heart failure
Conditions
Interventions
Trade Name: Sustanon 250
Pharmaceutical Form: Solution for injection
INN or Proposed INN: testosterone
CAS Number: -
Current Sponsor cod
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of a combined exercise rehabilitation and adjunctive testosterone therapy intervention for evoking improvements in exercise capacity, circulating inflammatory markers, cardiac and skeletal muscle function, indices of psychological health status and quality of life in chronic heart failure patients with low testosterone levels.;Secondary Objective: To obtain estimates of the variability of the primary outcome measure and an insight into the treatment effect resulting from combined testosterone therapy/exercise rehabilitation intervention versus exercise therapy alone, with the data being used in a subsequent power calculation for a larger-scale randomised controlled trial.; Primary end point(s): The primary outcome measures will be exercise capacity, assessed using the incremental shuttle-walk test (ISWT), at the 12 week time-point, in relation to baseline. Secondary outcome measures include:- circulating levels of inflammatory markers tests of cardiac and skeletal muscle function indices of psychological health status and quality of life. | — |
Countries
United Kingdom
Outcome results
None listed