Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure (TestoHF)
29 april 2021 uppdaterad av: Maria Janieire de Nazaré Nunes Alves, University of Sao Paulo General Hospital
Hormonal Anabolic Deficiency Associated With Neurovascular Alterations Predict Poor Prognosis 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
- Diagnostiskt test: Cardiopulmonary exercise test
- Diagnostiskt test: Muscle Sympathetic Nerve Activity
- Diagnostiskt test: Dual-energy X-ray absorptiometry
- Diagnostiskt test: Venous occlusion plethysmography
- Diagnostiskt test: Blood sample collection
- Diagnostiskt test: Dynamometers for Handgrip Strength
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
169
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
SP
-
Sao Paulo, SP, Brasilien, 05403-900
- Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Sannolikhetsprov
Studera befolkning
Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Low testosterone
Patients with HF and testosterone deficiency.
|
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.
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 (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Blood samples were drawn in the morning after 12h overnight fasting.
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
|
|
Normal testosterone
Patients with HF and normal plasma levels of testosterone.
|
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.
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 (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Blood samples were drawn in the morning after 12h overnight fasting.
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of testosterone deficiency on mortality
Tidsram: 2 years
|
Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting.
|
2 years
|
|
Impact of muscle sympathetic nerve activity on mortality
Tidsram: 2 years
|
Microneurography was used to assess the sympathetic nervous system.
|
2 years
|
|
Impact of neurovascular alterations on mortality
Tidsram: 2 years
|
Venous occlusion pletysmography was used to evaluate vasodilation.
|
2 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Impact of testosterone deficiency on body composition
Tidsram: 2 years
|
Body composition measurements were performed using dual-energy X-ray absorptiometry.
|
2 years
|
|
Impact of testosterone deficiency on functional capacity
Tidsram: 2 years
|
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
|
2 years
|
|
Impact of testosterone deficiency on strength
Tidsram: 2 years
|
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
|
2 years
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Maria Janieire de Nazaré Nunes Alves, PhD, InCor Heart Institute
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 juni 2016
Primärt slutförande (Faktisk)
23 mars 2020
Avslutad studie (Faktisk)
30 december 2020
Studieregistreringsdatum
Först inskickad
1 mars 2018
Först inskickad som uppfyllde QC-kriterierna
9 mars 2018
Första postat (Faktisk)
13 mars 2018
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AnabolicHormonesPrognosis
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