NCT01852994

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

December 15, 2016

Status Verified

May 1, 2013

Enrollment Period

6 years

First QC Date

March 11, 2013

Last Update Submit

December 14, 2016

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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 Arms (3)

Exercise training

OTHER

Aerobic and strength exercise training

Other: Exercise training

Testosterone replacement

OTHER

Testosterone replacement will be done quarterly

Drug: Testosterone replacement

Testosterone replacement+Exercise

OTHER

Both Testosterone replacement and Exercise will done

Drug: Testosterone replacementOther: Exercise training

Interventions

Testosterone replacementDRUG

Application quarterly of Testosterone Undecylate

Also known as: Testosterone Undecylate (Nebido)
Testosterone replacementTestosterone replacement+Exercise
Exercise trainingOTHER

Aerobic and strength exercise training

Exercise trainingTestosterone replacement+Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • chronic renal failure
  • normal testosterone
  • pace maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Heart Failure

Interventions

testosterone undecanoateExercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Janieire N Alves, MD; PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2013

First Posted

May 14, 2013

Study Start

July 1, 2009

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 15, 2016

Record last verified: 2013-05

Locations

BR(1)