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Completed

NCT Number: NCT03463226

Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality 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.

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo

São Paulo, 05403-900, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cardiopulmonary exercise test

Diagnostic Test

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.

Muscle Sympathetic Nerve Activity

Diagnostic Test

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

Diagnostic Test

Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.

Venous occlusion plethysmography

Diagnostic Test

Venous occlusion plethysmography was used to assess non-invasively blood flow.

Blood sample collection

Diagnostic Test

Blood samples were drawn in the morning after 12h overnight fasting.

Dynamometers for Handgrip Strength

Diagnostic Test

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

Primary outcomes

  1. Impact of testosterone deficiency on mortality

    Time frame: 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

    Time frame: 2 years

    Microneurography was used to assess the sympathetic nervous system.

  3. Impact of neurovascular alterations on mortality

    Time frame: 2 years

    Venous occlusion pletysmography was used to evaluate vasodilation.

Secondary outcomes

  1. Impact of testosterone deficiency on body composition

    Time frame: 2 years

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

  2. Impact of testosterone deficiency on functional capacity

    Time frame: 2 years

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

  3. Impact of testosterone deficiency on strength

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis in Male Patients With Heart Failure

Acronym: TestoHF

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2018
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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