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

Heart Failure Clinical Trial

Official title: Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure

Status Completed

Clinical Trial 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.

Clinical Trial Description

One hundred and fifty six patients have been enrolled so far. Methods were as described below: - Muscle sympathetic nerve activity (MSNA) was directly recorded from the peroneal nerve using the microneurography technique ; - All patients underwent symptom-limited cardiopulmonary exercise test performed on a cycle ergometer, using a ramp protocol with workload increments of 5 or 10 Watts per minute; - Body composition measurements were performed using dual-energy X-ray absorptiometry (DXA); - Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts; - Blood samples were drawn in the morning after 12h overnight fasting. The laboratory tests included B-type natriuretic peptide (BNP; pg/mL) plasma level, serum sodium (mEq/L), serum potassium (mEq/L), creatinine (mg/dL), haemoglobin level (g/dL), high-sensitivity C-reactive protein (CRP; mg/L), lipid profile (triglyceride, total cholesterol, high-density lipoprotein, and low-density lipoprotein; mg/dL), and fasting glucose (mg/dL). Blood sample to assess hormone plasma levels were also drawn at the same time: total testosterone (TT), free testosterone (FT), sex hormone binding globulin (SHBG), dehydroepiandrosterone sulfate (DHEAS), luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid stimulating hormone (TSH) and insulin-like growth factor 1 (IGF1). ;

Related Conditions & MeSH terms

• Heart Failure

• NCT number: NCT03463226
• Study type: Observational
• Source: University of Sao Paulo General Hospital
• Status: Completed
• Start date: June 30, 2016
• Completion date: December 30, 2020