- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03463226
Effects of Hormonal Anabolic Deficiency and Neurovascular Alterations on Mortality in Male Patients With Heart Failure (TestoHF)
29. april 2021 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
169
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
SP
-
Sao Paulo, SP, Brasilien, 05403-900
- Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Impact of testosterone deficiency on mortality
Tidsramme: 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
Tidsramme: 2 years
|
Microneurography was used to assess the sympathetic nervous system.
|
2 years
|
Impact of neurovascular alterations on mortality
Tidsramme: 2 years
|
Venous occlusion pletysmography was used to evaluate vasodilation.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Impact of testosterone deficiency on body composition
Tidsramme: 2 years
|
Body composition measurements were performed using dual-energy X-ray absorptiometry.
|
2 years
|
Impact of testosterone deficiency on functional capacity
Tidsramme: 2 years
|
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
|
2 years
|
Impact of testosterone deficiency on strength
Tidsramme: 2 years
|
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Maria Janieire de Nazaré Nunes Alves, PhD, InCor Heart Institute
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. juni 2016
Primær færdiggørelse (Faktiske)
23. marts 2020
Studieafslutning (Faktiske)
30. december 2020
Datoer for studieregistrering
Først indsendt
1. marts 2018
Først indsendt, der opfyldte QC-kriterier
9. marts 2018
Først opslået (Faktiske)
13. marts 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AnabolicHormonesPrognosis
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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