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Clinical Trials/NCT01852994
NCT01852994
Completed
Phase 4

Exercise Training and Testosterone Replacement in Heart Failure Patients

University of Sao Paulo General Hospital1 site in 1 country39 target enrollmentJuly 2009

Overview

Phase
Phase 4
Intervention
Exercise training
Conditions
Heart Failure
Sponsor
University of Sao Paulo General Hospital
Enrollment
39
Locations
1
Primary Endpoint
Microneurography
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 2009
End Date
July 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Factorial
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • chronic renal failure
  • normal testosterone
  • pace maker

Arms & Interventions

Exercise training

Aerobic and strength exercise training

Intervention: Exercise training

Testosterone replacement

Testosterone replacement will be done quarterly

Intervention: Testosterone replacement

Testosterone replacement+Exercise

Both Testosterone replacement and Exercise will done

Intervention: Testosterone replacement

Testosterone replacement+Exercise

Both Testosterone replacement and Exercise will done

Intervention: Exercise training

Outcomes

Primary Outcomes

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).

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

  • Cardiopulmonary exercise(4 months of exercise training/testosterone replacement)
  • Body composition(4 months of exercise training/testosterone replacement)
  • Muscle biopsy(4 months of exercise training/testosterone replacement)

Study Sites (1)

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