Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
São Paulo, 05403-900, Brazil
NCT Number: NCT03463226
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.
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Notify Me18 year–65 year
Male
Observational
São Paulo, 05403-900, Brazil
One hundred and fifty six patients have been enrolled so far. Methods were as described below:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Blood samples were drawn in the morning after 12h overnight fasting.
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
Time frame: 2 years
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
Time frame: 2 years
Microneurography was used to assess the sympathetic nervous system.
Time frame: 2 years
Venous occlusion pletysmography was used to evaluate vasodilation.
Time frame: 2 years
Body composition measurements were performed using dual-energy X-ray absorptiometry.
Time frame: 2 years
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
Time frame: 2 years
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
University of Sao Paulo General Hospital
Other
Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
Acronym: TestoHF
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