Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: Cardiopulmonary exercise testDiagnostic Test: Muscle Sympathetic Nerve ActivityDiagnostic Test: Dual-energy X-ray absorptiometryDiagnostic Test: Venous occlusion plethysmographyDiagnostic Test: Blood sample collectionDiagnostic Test: Dynamometers for Handgrip Strength
- Registration Number
- NCT03463226
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief 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.
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 169
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Low testosterone Cardiopulmonary exercise test Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Low testosterone Muscle Sympathetic Nerve Activity Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Low testosterone Dynamometers for Handgrip Strength Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Venous occlusion plethysmography Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Low testosterone Venous occlusion plethysmography Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Cardiopulmonary exercise test Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Dual-energy X-ray absorptiometry Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Low testosterone Blood sample collection Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Muscle Sympathetic Nerve Activity Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Low testosterone Dual-energy X-ray absorptiometry Patients with HF and testosterone deficiency. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Blood sample collection Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength Normal testosterone Dynamometers for Handgrip Strength Patients with HF and normal plasma levels of testosterone. * Cardiopulmonary exercise test * Muscle Sympathetic Nerve Activity * Dual-energy X-ray absorptiometry * Venous occlusion plethysmography * Blood sample collection * Dynamometers for Handgrip Strength
- Primary Outcome Measures
Name Time Method Impact of neurovascular alterations on mortality 2 years Venous occlusion pletysmography was used to evaluate vasodilation.
Impact of muscle sympathetic nerve activity on mortality 2 years Microneurography was used to assess the sympathetic nervous system.
Impact of testosterone deficiency on mortality 2 years Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
- Secondary Outcome Measures
Name Time Method Impact of testosterone deficiency on functional capacity 2 years All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
Impact of testosterone deficiency on body composition 2 years Body composition measurements were performed using dual-energy X-ray absorptiometry.
Impact of testosterone deficiency on strength 2 years Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
Trial Locations
- Locations (1)
Instituto do Coração do Hospital da ClÃnicas da Universidade de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil