Heart Failure
Conditions
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
Interventions
Application quarterly of Testosterone Undecylate
OTHERExercise training
Aerobic and strength exercise training
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* heart failure * hypogonadism * left ventricular fraction ejection \< 45%
Exclusion criteria
* chronic renal failure * normal testosterone * pace maker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microneurography | 4 months of exercise training/testosterone replacement | 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). |
| Forearm blood flow | 4 months of exercise training/testosterone replacement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | 4 months of exercise training/testosterone replacement | 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. |
| Cardiopulmonary exercise | 4 months of exercise training/testosterone replacement | 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. |
| Muscle biopsy | 4 months of exercise training/testosterone replacement | 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 |
Countries
Brazil
Outcome results
None listed