Exercise Training and Testosterone Replacement in Heart Failure Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients

Detailed Description
-----------------
In this study, we are evaluating: hospital length of stay and readmission muscle sympathetic nerve activity functional capacity body composition

Official Title
-----------------
Exercise Training and Testosterone Replacement in Heart Failure Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Drug: Testosterone replacement
* Other: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure hypogonadism left ventricular fraction ejection < 45% Exclusion Criteria: chronic renal failure normal testosterone pace maker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise training<br>Aerobic and strength exercise training | Other: Exercise training<br>* Aerobic and strength exercise training<br>|
| Other: Testosterone replacement<br>Testosterone replacement will be done quarterly | Drug: Testosterone replacement<br>* Application quarterly of Testosterone Undecylate<br>* Other names: Testosterone Undecylate (Nebido);|
| Other: Testosterone replacement+Exercise<br>Both Testosterone replacement and Exercise will done | Drug: Testosterone replacement<br>* Application quarterly of Testosterone Undecylate<br>* Other names: Testosterone Undecylate (Nebido);Other: Exercise training<br>* Aerobic and strength exercise training<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microneurography | Muscle sympathetic nerve activity (MSNA) is recorded directly from the peroneal nerve using the microneurography technique. Multiunit postganglionic muscle sympathetic nerve recordings is made using a tungsten microelectrode. All of the recordings of MSNA met previously established and described criteria. MSNA is quantified as burst frequency (bursts per minute). | 4 months of exercise training/testosterone replacement | 
| Forearm blood flow | Forearm blood flow is measured by venous occlusion plethysmography. The nondominant arm is elevated above heart level to ensure adequate venous drainage. A mercury-filled silastic tube attached to a low-pressure transducer is placed around the forearm and connected to a plethysmography. Forearm blood flow is determined on the basis of a minimum off four separate readings. Forearm vascular conductance is calculated by dividing forearm blood flow by mean arterial pressure times 100 and expressed in arbitrary units. | 4 months of exercise training/testosterone replacement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiopulmonary exercise | The maximal cardiopulmonary test is carried out on a bike using a ramp protocol with workload increment every minute with energetic demand of about 1 metabolic equivalent(MET) per minute or 3.5 mL/Kg.min of oxygen uptake. | 4 months of exercise training/testosterone replacement | 
| Body composition | Body composition and bone mineral density is determined by dual energy x-ray absorptiometry using densitometry equipment (Hologic), at the following regions: lumbar spine, femoral neck, total femur and total body. Appendicular lean mass is calculated as the sum of arms and legs lean soft tissue masses, assuming that all non-fat and non-bone tissue is skeletal muscle. The total body fat is expressed in grams and as a percentage of body weight. | 4 months of exercise training/testosterone replacement | 
| Muscle biopsy | The muscle biopsy is obtained with a single entry into the muscle 5-10 minutes after administering the local anesthetic following an incision through the skin. A portion of the muscle ( 10 mg) is processed to evaluate 1) muscle fiber type and 2) cross-sectional area | 4 months of exercise training/testosterone replacement |