Exercise Training and Testosterone Replacement in Heart Failure Patients

NCT ID: NCT01852994

Last Updated: 2016-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2015-07-31

Brief Summary

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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

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In this study, we are evaluating:

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

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Exercise training

Aerobic and strength exercise training

Group Type OTHER

Exercise training

Intervention Type OTHER

Aerobic and strength exercise training

Testosterone replacement

Testosterone replacement will be done quarterly

Group Type OTHER

Testosterone replacement

Intervention Type DRUG

Application quarterly of Testosterone Undecylate

Testosterone replacement+Exercise

Both Testosterone replacement and Exercise will done

Group Type OTHER

Testosterone replacement

Intervention Type DRUG

Application quarterly of Testosterone Undecylate

Exercise training

Intervention Type OTHER

Aerobic and strength exercise training

Interventions

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Testosterone replacement

Application quarterly of Testosterone Undecylate

Intervention Type DRUG

Exercise training

Aerobic and strength exercise training

Intervention Type OTHER

Other Intervention Names

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Testosterone Undecylate (Nebido)

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* chronic renal failure
* normal testosterone
* pace maker
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Janieire N Alves, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Testosterone

Identifier Type: -

Identifier Source: org_study_id