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

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Вход / Регистрация
Линкът е запазен в клипборда
СъстояниеНабиране
Спонсори
University of Sao Paulo General Hospital
Сътрудници
Fundação de Amparo à Pesquisa do Estado de São Paulo

Ключови думи

Резюме

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.

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

Heart Failure

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

ArmИнтервенция / 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 проучванеMale
Метод за вземане на пробиProbability Sample
Приема здрави доброволциДа
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]

Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.

2. Impact of muscle sympathetic nerve activity on mortality [2 years]

Microneurography was used to assess the sympathetic nervous system.

3. Impact of neurovascular alterations on mortality [2 years]

Venous occlusion pletysmography was used to evaluate vasodilation.

Вторични изходни мерки

1. Impact of testosterone deficiency on body composition [2 years]

Body composition measurements were performed using dual-energy X-ray absorptiometry.

2. Impact of testosterone deficiency on functional capacity [2 years]

All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.

3. Impact of testosterone deficiency on strength [2 years]

Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.

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