Exercise Training and Testosterone Replacement in Heart Failure Patients
Primary Purpose
Heart Failure
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Testosterone replacement
Exercise training
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- heart failure
- hypogonadism
- left ventricular fraction ejection < 45%
Exclusion Criteria:
- chronic renal failure
- normal testosterone
- pace maker
Sites / Locations
- Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Exercise training
Testosterone replacement
Testosterone replacement+Exercise
Arm Description
Aerobic and strength exercise training
Testosterone replacement will be done quarterly
Both Testosterone replacement and Exercise will done
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
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.
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
Full Information
NCT ID
NCT01852994
First Posted
March 11, 2013
Last Updated
December 14, 2016
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01852994
Brief Title
Exercise Training and Testosterone Replacement in Heart Failure Patients
Official Title
Exercise Training and Testosterone Replacement in Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Other
Arm Description
Aerobic and strength exercise training
Arm Title
Testosterone replacement
Arm Type
Other
Arm Description
Testosterone replacement will be done quarterly
Arm Title
Testosterone replacement+Exercise
Arm Type
Other
Arm Description
Both Testosterone replacement and Exercise will done
Intervention Type
Drug
Intervention Name(s)
Testosterone replacement
Other Intervention Name(s)
Testosterone Undecylate (Nebido)
Intervention Description
Application quarterly of Testosterone Undecylate
Intervention Type
Other
Intervention Name(s)
Exercise training
Intervention Description
Aerobic and strength exercise training
Primary Outcome Measure Information:
Title
Microneurography
Description
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).
Time Frame
4 months of exercise training/testosterone replacement
Title
Forearm blood flow
Description
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.
Time Frame
4 months of exercise training/testosterone replacement
Secondary Outcome Measure Information:
Title
Cardiopulmonary exercise
Description
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.
Time Frame
4 months of exercise training/testosterone replacement
Title
Body composition
Description
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.
Time Frame
4 months of exercise training/testosterone replacement
Title
Muscle biopsy
Description
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
Time Frame
4 months of exercise training/testosterone replacement
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
heart failure
hypogonadism
left ventricular fraction ejection < 45%
Exclusion Criteria:
chronic renal failure
normal testosterone
pace maker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Janieire N Alves, MD; PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
12. IPD Sharing Statement
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Exercise Training and Testosterone Replacement in Heart Failure Patients
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