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

Heart Failure Clinical Trial

— TestoHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463226
• Other study ID #: AnabolicHormonesPrognosis
• Status: Completed
• Start date: June 30, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: December 30, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• Cardiopulmonary exercise 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
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
Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
• Venous occlusion plethysmography
Venous occlusion plethysmography was used to assess non-invasively blood flow.
• Blood sample collection
Blood samples were drawn in the morning after 12h overnight fasting.
• Dynamometers for Handgrip Strength
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.

Locations

Country	Name	City	State
Brazil	Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo	Sao Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of testosterone deficiency on mortality	Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.	2 years
Primary	Impact of muscle sympathetic nerve activity on mortality	Microneurography was used to assess the sympathetic nervous system.	2 years
Primary	Impact of neurovascular alterations on mortality	Venous occlusion pletysmography was used to evaluate vasodilation.	2 years
Secondary	Impact of testosterone deficiency on body composition	Body composition measurements were performed using dual-energy X-ray absorptiometry.	2 years
Secondary	Impact of testosterone deficiency on functional capacity	All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.	2 years
Secondary	Impact of testosterone deficiency on strength	Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.	2 years