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

29. april 2021 oppdatert 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert 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).

Studietype

Observasjonsmessig

Registrering (Faktiske)

169

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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
Diagnostisk 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.
Diagnostisk test: 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.
Diagnostisk test: 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.
Diagnostisk test: Venous occlusion plethysmography
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Diagnostisk test: Blood sample collection
Blood samples were drawn in the morning after 12h overnight fasting.
Diagnostisk test: 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
Diagnostisk 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.
Diagnostisk test: 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.
Diagnostisk test: 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.
Diagnostisk test: Venous occlusion plethysmography
Venous occlusion plethysmography was used to assess non-invasively blood flow.
Diagnostisk test: Blood sample collection
Blood samples were drawn in the morning after 12h overnight fasting.
Diagnostisk test: Dynamometers for Handgrip Strength
Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Sao Paulo General Hospital

Samarbeidspartnere

Fundação de Amparo à Pesquisa do Estado de São Paulo

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

30. juni 2016

Primær fullføring (Faktiske)

23. mars 2020

Studiet fullført (Faktiske)

30. desember 2020

Datoer for studieregistrering

Først innsendt

1. mars 2018

Først innsendt som oppfylte QC-kriteriene

9. mars 2018

Først lagt ut (Faktiske)

13. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. mai 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2021

Sist bekreftet

1. april 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AnabolicHormonesPrognosis

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

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Studerer et amerikansk FDA-regulert medikamentprodukt

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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