NCT03463226

Brief Summary

Heart failure (HF) has been associated with chronic deleterious effects on skeletal muscle, endocrine system, vasculature and sympathetic nervous system. These alterations have a significant impact on quality of life, leading to a reduction in functional capacity and limited symptoms, which involve dyspnea and fatigue. The investigators tested the hypothesis that hormonal anabolic deficiency associated with neurovascular alterations may worsen the prognosis of patients with heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Longer than P75 for all trials

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

June 30, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

March 1, 2018

Last Update Submit

April 29, 2021

Conditions

Heart Failure

Keywords

Testosterone DeficiencySympathetic overactivityExercise Intolerance

Outcome Measures

Primary Outcomes (3)

  • Impact of testosterone deficiency on mortality

    Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.

    2 years

  • Impact of muscle sympathetic nerve activity on mortality

    Microneurography was used to assess the sympathetic nervous system.

    2 years

  • Impact of neurovascular alterations on mortality

    Venous occlusion pletysmography was used to evaluate vasodilation.

    2 years

Secondary Outcomes (3)

  • Impact of testosterone deficiency on body composition

    2 years

  • Impact of testosterone deficiency on functional capacity

    2 years

  • Impact of testosterone deficiency on strength

    2 years

Study Arms (2)

Low testosterone

Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength

Diagnostic Test: Cardiopulmonary exercise testDiagnostic Test: Muscle Sympathetic Nerve ActivityDiagnostic Test: Dual-energy X-ray absorptiometryDiagnostic Test: Venous occlusion plethysmographyDiagnostic Test: Blood sample collectionDiagnostic Test: Dynamometers for Handgrip Strength

Normal testosterone

Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength

Diagnostic Test: Cardiopulmonary exercise testDiagnostic Test: Muscle Sympathetic Nerve ActivityDiagnostic Test: Dual-energy X-ray absorptiometryDiagnostic Test: Venous occlusion plethysmographyDiagnostic Test: Blood sample collectionDiagnostic Test: Dynamometers for Handgrip Strength

Interventions

Cardiopulmonary exercise testDIAGNOSTIC_TEST

Oxygen consumption (VO2) and carbon dioxide output (VCO2) were measured by means of gas exchange on a breath-by-breath basis. The patients were initially monitored for 2 minutes at rest when seated on the ergometer, after that they were instructed to pedal at a pace of 60-70 rpm and the completion of the test occurred when, in spite of verbal encouragement, the patient reached maximal volitional fatigue.

Low testosteroneNormal testosterone
Muscle Sympathetic Nerve ActivityDIAGNOSTIC_TEST

Multiunit post-ganglionic muscle sympathetic nerve recordings were made using a tungsten microelectrode placed in the peroneal nerve near the fibular head. Nerve signals were amplified by a factor of 50,000 to 100,000 and band-pass filtered (700 to 2000 Hz). For recording and analysis, nerve activity was rectified and integrated (time constant 0.1 seconds) to obtain a mean voltage display of sympathetic nerve activity.

Low testosteroneNormal testosterone
Dual-energy X-ray absorptiometryDIAGNOSTIC_TEST

Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.

Low testosteroneNormal testosterone
Venous occlusion plethysmographyDIAGNOSTIC_TEST

Venous occlusion plethysmography was used to assess non-invasively blood flow.

Low testosteroneNormal testosterone
Blood sample collectionDIAGNOSTIC_TEST

Blood samples were drawn in the morning after 12h overnight fasting.

Low testosteroneNormal testosterone
Dynamometers for Handgrip StrengthDIAGNOSTIC_TEST

Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.

Low testosteroneNormal testosterone

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).

You may qualify if:

  • age between 18 and 65 years old;
  • at least1 year of diagnosed HF;
  • left ventricular ejection fraction (LVEF) lower than 40% measured by echocardiography;
  • non-ischaemic and ischaemic aetiologies;
  • compensated HF with optimal medication for at least 3 months prior the study;
  • New York Heart Association (NYHA) class of I to IV.

You may not qualify if:

  • patients with autonomic diabetic neuropathy;
  • patients with chronic renal failure with haemodialysis;
  • heart transplantation;
  • presence of pacemaker;
  • patients with muscular dystrophy (i.e. Duchenne muscular dystrophy);
  • patients submitted to any hormonal treatment;
  • history of cancer;
  • ongoing infection;
  • myocardial infarction with percutaneous coronary intervention or revascularization 6 months prior to the study entry.

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

Exercise TestAbsorptiometry, Photon

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative TechniquesRadiographyDiagnostic ImagingDensitometryPhotometryChemistry Techniques, Analytical

Study Officials

  • Maria Janieire de Nazaré Nunes Alves, PhD

    InCor Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 1, 2018

First Posted

March 13, 2018

Study Start

June 30, 2016

Primary Completion

March 23, 2020

Study Completion

December 30, 2020

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)