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The main of the study is to evaluate the effect of testosterone on ventricular repolarization in patients with mild heart failure, at risk for sudden cardiac death. The electrocardiographic markers studied are QT variability index, the short term variability index.
Background:
It has been widely demonstrated in experimental cardiology that estrogen may play a protective role on cardiovascular system, reducing myocardial damage in ischemia-reperfusion injury. Poor are the contributions of the effects of estrogen in the presence of testosterone which also showed potentially cardioprotective effects. Recently it has emerged strong evidence showing that the increase in the repolarization phase of myocardial duration and its temporal dispersion are predictive markers of cardiac death in post-ischemic dilated cardiomyopathy. In addition, the temporal dispersion of the final part of the repolarization phase (Tpeak-Tend) is specifically predictive for sudden cardiac death. In fact, the investigators propose the following plan of experimental study. It will be measured by the duration of the repolarization phase and its basal temporal dispersion and the peak of the heart rate obtained during stress test, in male subjects before and during testosterone replacement therapy.
Patients evaluation baseline, after 1 month and after 6 months of follow up:
Endocrinological evaluation with measurement of body weight, height, BMI calculation and (digital rectal examination) DRE, blood sample.
Laboratory:
Dosage of serum total testosterone, total and free PSA, blood count.
Cardiological evaluation:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypogonadic with chronic heart failure | Experimental | patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II), and hypogonadism (plasma testosterone levels <11.4 nmol / L); |
|
| Hypogonadic | Experimental | patients just with hypogonadism (testosterone <11.4 nmol / L) in the absence of documented cardiovascular disease |
|
| chronic heart failure | No Intervention | patients suffering from mild to moderate heart failure (LVEF ≥ 40%, NYHA I-II) with normal testosterone levels(plasma testosterone levels > 11.4 nmol / L), in optimized standard therapy for heart failure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone Undecanoate | Drug | just hypogonadic patients enrolled received hormone replacement therapy with testosterone undecanoate 1000 mg/4ml intramuscular (IM) at baseline, after 6 weeks and 12 weeks after the first evaluation |
| Measure | Description | Time Frame |
|---|---|---|
| QT duration reduction | Reduction of the absolute QT interval value and its space and time dispersion | baseline (before testosterone administration), after 1 month and after 6 months of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| hypogonadism treatment | restoration of normal testosterone blood levels | baseline (before testosterone administration), after 1 month and after 6 months of follow up |
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Inclusion Criteria:
Exclusion Criteria:
just male patients with hypogonadism or chronic heart failure or both are eligible
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| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C010792 | testosterone undecanoate |
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