Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure

NCT03463226 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 169

Last updated 2021-05-03

No results posted yet for this study

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Cardiopulmonary exercise 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.

DIAGNOSTIC_TEST

Muscle Sympathetic Nerve Activity

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.

DIAGNOSTIC_TEST

Dual-energy X-ray absorptiometry

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

DIAGNOSTIC_TEST

Venous occlusion plethysmography

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

DIAGNOSTIC_TEST

Blood sample collection

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

DIAGNOSTIC_TEST

Dynamometers for Handgrip Strength

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

Sponsors & Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV
  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Maria Janieire de Nazaré Nunes Alves, PhD · InCor Heart Institute

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-03-23
Completion
2020-12-30

Countries

  • Brazil

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03463226 on ClinicalTrials.gov