The effects of testosterone therapy in men with pulmonary hypertensio
- Conditions
- Pulmonary Hypertension
- Registration Number
- EUCTR2005-000049-12-GB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Male aged over 18 on regular medication unlikely to change
Clinical pulmonary hypertension, diagnosed 3 months and clinically stable
Pulmonary hypertension diagnosed on echocardiography or by right heart catheter: peak systolic pulmonary artery pressure>50mmHg, mean 30mmHg.
NYHA class II or III
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
Unable to perform shuttle walk test or comply with medication
Malignancy e.g. breast and prostate.
Left heart failure – Ejection fraction <40% on echocardiography
Nephrotic syndrome
History of primary liver tumours
Hypercalcaemia and hypercalciuria
Hormone manipulating therapy
PSA above the normal range
NYHA class IV
Current participation in other research projects
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of testosterone supplementation as add on therapy in men with pulmonary hypertension as defined by an increase in shuttle walk distance;Secondary Objective: To evaluate the effects of testosterone supplementation as add on therapy on cardiorespiratory, endoparacrine and quality of life measures in men with pulmonary hypertension;Primary end point(s): Change in functional capacity defined as increase in distance walked on shuttle walk testing
- Secondary Outcome Measures
Name Time Method