Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure
Ключови думи
Резюме
Описание
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).
Дати
Последна проверка: | 02/29/2020 |
Първо изпратено: | 02/28/2018 |
Очаквано записване подадено: | 03/08/2018 |
Първо публикувано: | 03/12/2018 |
Изпратена последна актуализация: | 03/22/2020 |
Последна актуализация публикувана: | 03/23/2020 |
Действителна начална дата на проучването: | 06/29/2016 |
Приблизителна дата на първично завършване: | 03/22/2020 |
Очаквана дата на завършване на проучването: | 12/29/2020 |
Състояние или заболяване
Интервенция / лечение
Diagnostic Test: Cardiopulmonary exercise test
Diagnostic Test: Muscle Sympathetic Nerve Activity
Diagnostic Test: Dual-energy X-ray absorptiometry
Diagnostic Test: Venous occlusion plethysmography
Diagnostic Test: Blood sample collection
Diagnostic Test: Dynamometers for Handgrip Strength
Фаза
Групи за ръце
Arm | Интервенция / лечение |
---|---|
Low testosterone 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 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 |
Критерии за допустимост
Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
Полове, допустими за проучване | Male |
Метод за вземане на проби | Probability Sample |
Приема здрави доброволци | Да |
Критерии | 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. |
Резултат
Първични изходни мерки
1. Impact of testosterone deficiency on mortality [2 years]
2. Impact of muscle sympathetic nerve activity on mortality [2 years]
3. Impact of neurovascular alterations on mortality [2 years]
Вторични изходни мерки
1. Impact of testosterone deficiency on body composition [2 years]
2. Impact of testosterone deficiency on functional capacity [2 years]
3. Impact of testosterone deficiency on strength [2 years]