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Exercise Training and Testosterone Replacement in Heart Failure Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852994
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Testosterone replacement Other: Exercise training Phase 4

Detailed Description:

In this study, we are evaluating:

  • hospital length of stay and readmission
  • muscle sympathetic nerve activity
  • functional capacity
  • body composition

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Exercise Training and Testosterone Replacement in Heart Failure Patients
Study Start Date : July 2009
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Exercise training
Aerobic and strength exercise training
Other: Exercise training
Aerobic and strength exercise training

Testosterone replacement
Testosterone replacement will be done quarterly
Drug: Testosterone replacement
Application quarterly of Testosterone Undecylate
Other Name: Testosterone Undecylate (Nebido)

Testosterone replacement+Exercise
Both Testosterone replacement and Exercise will done
Drug: Testosterone replacement
Application quarterly of Testosterone Undecylate
Other Name: Testosterone Undecylate (Nebido)

Other: Exercise training
Aerobic and strength exercise training




Primary Outcome Measures :
  1. Microneurography [ Time Frame: 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).

  2. Forearm blood flow [ Time Frame: 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 :
  1. Cardiopulmonary exercise [ Time Frame: 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.

  2. Body composition [ Time Frame: 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.

  3. Muscle biopsy [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • heart failure
  • hypogonadism
  • left ventricular fraction ejection < 45%

Exclusion Criteria:

  • chronic renal failure
  • normal testosterone
  • pace maker

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852994


Locations
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Brazil
Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Maria Janieire N Alves, MD; PhD University of Sao Paulo
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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01852994    
Other Study ID Numbers: Testosterone
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: May 2013
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Methyltestosterone
Testosterone
Testosterone undecanoate
Testosterone enanthate
Testosterone 17 beta-cypionate
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents