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

29 avril 2021 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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).

Type d'étude

Observationnel

Inscription (Réel)

169

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Brésil
    • SP
      • Sao Paulo, SP, Brésil, 05403-900
        • Instituto do Coração do Hospital da Clínicas da Universidade de Sao Paulo

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

Patients with heart failure recruited at Clinical Unit of Myocardiopathy at General Hospital of the University of São Paulo Medical School (UNCAR/HC-FMUSP).

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: Cohorte
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Low testosterone

Patients with HF and testosterone deficiency.

  • Cardiopulmonary exercise test
  • Muscle Sympathetic Nerve Activity
  • Dual-energy X-ray absorptiometry
  • Venous occlusion plethysmography
  • Blood sample collection
  • Dynamometers for Handgrip Strength
Test diagnostique: 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.
Test diagnostique: 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.
Test diagnostique: 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.
Test diagnostique: Venous occlusion plethysmography
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Test diagnostique: Blood sample collection
Blood samples were drawn in the morning after 12h overnight fasting.
Test diagnostique: Dynamometers for Handgrip Strength
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.

  • Cardiopulmonary exercise test
  • Muscle Sympathetic Nerve Activity
  • Dual-energy X-ray absorptiometry
  • Venous occlusion plethysmography
  • Blood sample collection
  • Dynamometers for Handgrip Strength
Test diagnostique: 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.
Test diagnostique: 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.
Test diagnostique: 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.
Test diagnostique: Venous occlusion plethysmography
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Test diagnostique: Blood sample collection
Blood samples were drawn in the morning after 12h overnight fasting.
Test diagnostique: Dynamometers for Handgrip Strength
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Impact of testosterone deficiency on mortality
Délai: 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
Délai: 2 years
Microneurography was used to assess the sympathetic nervous system.
2 years
Impact of neurovascular alterations on mortality
Délai: 2 years
Venous occlusion pletysmography was used to evaluate vasodilation.
2 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Impact of testosterone deficiency on body composition
Délai: 2 years
Body composition measurements were performed using dual-energy X-ray absorptiometry.
2 years
Impact of testosterone deficiency on functional capacity
Délai: 2 years
All patients underwent symptom-limited cardiopulmonary exercise test to measure functional capacity.
2 years
Impact of testosterone deficiency on strength
Délai: 2 years
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
2 years

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Sao Paulo General Hospital

Collaborateurs

Fundação de Amparo à Pesquisa do Estado de São Paulo

Les enquêteurs

  • Chercheur principal: Maria Janieire de Nazaré Nunes Alves, PhD, InCor Heart Institute

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

30 juin 2016

Achèvement primaire (Réel)

23 mars 2020

Achèvement de l'étude (Réel)

30 décembre 2020

Dates d'inscription aux études

Première soumission

1 mars 2018

Première soumission répondant aux critères de contrôle qualité

9 mars 2018

Première publication (Réel)

13 mars 2018

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 mai 2021

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 avril 2021

Dernière vérification

1 avril 2021

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • AnabolicHormonesPrognosis

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

Non

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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