Exercise Training and Testosterone Replacement in Heart Failure Patients

Heart Failure Clinical Trial

Official title:

Exercise Training and Testosterone Replacement in Heart Failure Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852994
• Other study ID #: Testosterone
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2013
• Last updated: December 14, 2016
• Start date: July 2009
• Est. completion date: July 2015

Study information

• Verified date: May 2013
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

In this study, we are evaluating:

• hospital length of stay and readmission

• muscle sympathetic nerve activity

• functional capacity

• body composition

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• heart failure

• hypogonadism

• left ventricular fraction ejection < 45%

Exclusion Criteria:

• chronic renal failure

• normal testosterone

• pace maker

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Testosterone replacement
Application quarterly of Testosterone Undecylate

Other:
• Exercise training
Aerobic and strength exercise training

Locations

Country	Name	City	State
Brazil	Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	4 months of exercise training/testosterone replacement	Yes
Primary	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.	4 months of exercise training/testosterone replacement	Yes
Secondary	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.	4 months of exercise training/testosterone replacement	Yes
Secondary	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.	4 months of exercise training/testosterone replacement	Yes
Secondary	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	4 months of exercise training/testosterone replacement	Yes