E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
|
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The end of the trial will be classed as the date when the last patient has attended and performed their last post-intervention assessment. Following this visit, and once the data has been analysed and input, the database will be locked. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |