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
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
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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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