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Completed

NCT Number: NCT01852994

Exercise Training and Testosterone Replacement in Heart Failure Patients

The purpose of this study is to determine if exercise training with or without testosterone replacement can improve cardiopathy in heart failure patients

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

About this study

In this study, we are evaluating:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • chronic renal failure
  • normal testosterone
  • pace maker

Treatment and study plan

Testosterone replacement

Drug

Application quarterly of Testosterone Undecylate

Other names: Testosterone Undecylate (Nebido)

Exercise training

Other

Aerobic and strength exercise training

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 14, 2013
Registry last updated
Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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