Clinical trial NCT03463226: Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure
Official title: Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Testosterone Deficiency
Sympathetic overactivity
Exercise Intolerance
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2018-03-13
Enrollment: 169
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Impact of testosterone deficiency on mortality
timeFrame: 2 years
measure: Impact of muscle sympathetic nerve activity on mortality
timeFrame: 2 years
measure: Impact of neurovascular alterations on mortality
timeFrame: 2 years
Secondary outcomes:
measure: Impact of testosterone deficiency on body composition
timeFrame: 2 years
measure: Impact of testosterone deficiency on functional capacity
timeFrame: 2 years
measure: Impact of testosterone deficiency on strength
timeFrame: 2 years
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
state: SP
Study officials:
affiliation: InCor Heart Institute
name: Maria Janieire de Nazaré Nunes Alves, PhD
role: PRINCIPAL_INVESTIGATOR
References: