Exercise Training and Testosterone Replacement in Heart Failure Patients
- Conditions
- Heart Failure
- Interventions
- Other: Exercise training
- Registration Number
- NCT01852994
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 39
- heart failure
- hypogonadism
- left ventricular fraction ejection < 45%
- chronic renal failure
- normal testosterone
- pace maker
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Testosterone replacement Testosterone replacement Testosterone replacement will be done quarterly Exercise training Exercise training Aerobic and strength exercise training Testosterone replacement+Exercise Testosterone replacement Both Testosterone replacement and Exercise will done Testosterone replacement+Exercise Exercise training Both Testosterone replacement and Exercise will done
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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
Trial Locations
- Locations (1)
Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil