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

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Exercise training; Drug: Testosterone replacement

Detailed Description

In this study, we are evaluating:

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

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-900
      • Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

• chronic renal failure
• normal testosterone
• pace maker

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Exercise training; Aerobic and strength exercise training	Other: Exercise training; Aerobic and strength exercise training
Other: Testosterone replacement; Testosterone replacement will be done quarterly	Drug: Testosterone replacement; Application quarterly of Testosterone Undecylate; Other Names: Testosterone Undecylate (Nebido)
Other: Testosterone replacement+Exercise; Both Testosterone replacement and Exercise will done	Other: Exercise training; Aerobic and strength exercise training; Drug: Testosterone replacement; Application quarterly of Testosterone Undecylate; Other Names: Testosterone Undecylate (Nebido)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Principal Investigator: Maria Janieire N Alves, MD; PhD, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimate): May 14, 2013

Study Record Updates

• Last Update Posted (Estimate): December 15, 2016
• Last Update Submitted That Met QC Criteria: December 14, 2016
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure; Physiological Effects of Drugs; Antineoplastic Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Androgens; Anabolic Agents; Testosterone; Methyltestosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
• Other Study ID Numbers: Testosterone