Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Impact of neurovascular alterations on mortality
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Impact of neurovascular alterations on mortality
时间窗: 2 years
Venous occlusion pletysmography was used to evaluate vasodilation.
Impact of muscle sympathetic nerve activity on mortality
时间窗: 2 years
Microneurography was used to assess the sympathetic nervous system.
Impact of testosterone deficiency on mortality
时间窗: 2 years
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
次要结局
- Impact of testosterone deficiency on functional capacity(2 years)
- Impact of testosterone deficiency on body composition(2 years)
- Impact of testosterone deficiency on strength(2 years)
研究者
Maria Janieire de Nazaré Nunes Alves
PhD
University of Sao Paulo General Hospital