Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure (TestoHF)
2021年4月29日 更新者：Maria Janieire de Nazaré Nunes Alves、University of Sao Paulo General Hospital
Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
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.
研究概览
地位
完全的
条件
详细说明
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).
研究类型
观察性的
注册 (实际的)
169
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
SP
-
Sao Paulo、SP、巴西、05403-900
- Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
概率样本
研究人群
Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Low testosterone
Patients with HF and testosterone deficiency.
|
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.
|
|
Normal testosterone
Patients with HF and normal plasma levels of testosterone.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Impact of testosterone deficiency on mortality
大体时间：2 years
|
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
|
2 years
|
|
Impact of muscle sympathetic nerve activity on mortality
大体时间：2 years
|
Microneurography was used to assess the sympathetic nervous system.
|
2 years
|
|
Impact of neurovascular alterations on mortality
大体时间：2 years
|
Venous occlusion pletysmography was used to evaluate vasodilation.
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Impact of testosterone deficiency on body composition
大体时间：2 years
|
Body composition measurements were performed using dual-energy X-ray absorptiometry.
|
2 years
|
|
Impact of testosterone deficiency on functional capacity
大体时间：2 years
|
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
|
2 years
|
|
Impact of testosterone deficiency on strength
大体时间：2 years
|
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
|
2 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Maria Janieire de Nazaré Nunes Alves, PhD、InCor Heart Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年6月30日
初级完成 (实际的)
2020年3月23日
研究完成 (实际的)
2020年12月30日
研究注册日期
首次提交
2018年3月1日
首先提交符合 QC 标准的
2018年3月9日
首次发布 (实际的)
2018年3月13日
研究记录更新
最后更新发布 (实际的)
2021年5月3日
上次提交的符合 QC 标准的更新
2021年4月29日
最后验证
2021年4月1日
更多信息
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