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- Ensaio Clínico NCT00756366
CPAP Therapy in Patients With Heart Failure and Obstructive Sleep Apnea. (PET-OSA)
Effects of Continuous Positive Airway Pressure Therapy on Myocardial Energetics and Sympathetic Nerve Function in Patients With Heart Failure and Obstructive Sleep Apnea.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
OSA and heart failure (HF) are states of increased afterload, metabolic demand and sympathetic nervous system(SNS) activation. In patients with OSA and HF, CPAP initially may reduce LV stroke volume(SV) but subsequently improves LV function. This may relate to an early beneficial effect on myocardial energetics through early reduction in metabolic demand that subsequently leads to improved efficiency of LV contraction. However, it is not clear whether CPAP favourably affects cardiac energetics. Any such benefit may also relate to reduced SNS activation with CPAP therapy. However its effect on myocardial SN function is also not well studied. We propose to evaluate the temporal effect of CPAP on daytime 1) oxidative metabolism; 2) the WMI as an estimate of mechanical efficiency; 3) myocardial SN pre-synaptic function; and 4) HR variability in patients with OSA and HF. We will also determine whether these parameters are altered compared to a group of patients with HF without OSA. In conjunction with echocardiographic measures of LV stroke work, PET derived [11C]acetate kinetics will be used as a measure of oxidative metabolism, to determine the work metabolic index (WMI). [11C]HED retention will be used to measure cardiac SN pre-synaptic function.
HYPOTHESES
Primary Hypotheses:
In patients with chronic stable HF and OSA, 6-8 weeks' of CPAP demonstrates:
- beneficial effects on daytime myocardial metabolism leading to a reduction in the rate of oxidative metabolism as measured by [11C]acetate kinetics using PET imaging;
- improvement in energy transduction from oxidative metabolism to stroke work as measured by an increase in the daytime work-metabolic index.
Secondary Hypotheses:
In patients with chronic stable heart failure and OSA,
- CPAP leads to an early (1 week'') reduction in daytime oxidative metabolism that precedes the improvement in work-metabolic index, indicating an early energy sparing effect;
- CPAP leads to i) an increase in daytime myocardial SN pre-synaptic function as measured by increased [11C]HED retention on PET imaging, and ii) a parallel decrease in sympathetic and increase in vagal modulation of sino-atrial discharge (i.e. heart rate (HR) variability)
- there is impaired daytime myocardial oxidative metabolism, work-metabolic index, and myocardial sympathetic nerve function compared to patients with heart failure without OSA.
'original protocol indicated 1 month follow up but was changed to 6-8 weeks in order to accommodate patient logistics and imaging centre scheduling.
''Logistics did not permit all patients to complete 1 week scan.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Ontario
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Ottawa, Ontario, Canadá, K1Y 4W7
- University of Ottawa Heart Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- systolic LV dysfunction (LVEF<40%; by echocardiography, radionuclide or contrast ventriculography)
- symptoms of HF: NYHA Class II to III
- stable condition with optimally tolerated medical therapy, unchanged for > 4 weeks
- Obstructive sleep apnea (OSA) diagnosed on nocturnal polysomnogram with an apnea/hypopnea index (AHI) >15 events/hr and a predominantly obstructive pattern(more than 80% of events being obstructive in nature)OR
- no OSA: defined as AHI<5 (control subjects) will be matched with the OSA group for gender, age + 5 years, ejection fraction (EF) +5%, drug therapy and etiology of HF (ischemic or non-ischemic)
- willingness to receive CPAP therapy
- informed consent
Exclusion Criteria:
- unstable angina or recent myocardial infarction (MI) (<4 weeks prior)
- severe valvular dysfunction
- requirement for revascularization
- a permanent pacemaker
- atrial fibrillation
- significant ventricular arrhythmia or sinus node dysfunction
- life expectancy less than 1 year due to other co-morbidity
- significant restrictive and obstructive lung disease
- concomitant treatment or use of: tricyclic antidepressants, cocaine or drugs which may alter catecholamine uptake; or hypnotic, benzodiazepine, selective serotonin reuptake inhibitors(SSRI), neuroleptic, narcotic or other medications which may alter sleep or sleep-disordered breathing
- central sleep apnea
- other primary sleep disorder (i.e. periodic limb movement with arousal >5 events/hr, narcolepsy, rapid eye movement (REM) behaviour disorder)
- requiring supplemental oxygen therapy at night
- debilitating daytime somnolence (indicating clear-cut indication for CPAP therapy)
- a previous cardiac transplant
- a large transmural scar defined on previous perfusion imaging(severe resting perfusion defect (<50% uptake) occupying >25% of the LV)148-150
- age < 18 years
- pregnant or breast-feeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: 1
Heart Failure-OSA Group, randomized to early CPAP
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PET imaging at baseline, 1 week and 6-8 weeks.
CPAP begins after baseline PET scan.
Outros nomes:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Outros nomes:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Outros nomes:
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Comparador Ativo: 2
Heart Failure-OSA Group, randomized to late CPAP
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PET imaging at baseline, 1 week and 6-8 weeks.
CPAP begins after baseline PET scan.
Outros nomes:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Outros nomes:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Outros nomes:
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Outro: 3
Heart Failure- no OSA, no CPAP therapy, observational group
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PET imaging at baseline, 1 week and 6-8 weeks.
CPAP begins after baseline PET scan.
Outros nomes:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Outros nomes:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI
Prazo: at 6-8 weeks
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The differences in the measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI will be analyzed using t-tests for the treatment groups
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at 6-8 weeks
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C-11 Hydroxyephedrine (HED) retention
Prazo: 6-8 weeks
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C-11 HED retention will be a measure myocardial SN pre-synaptic function in treatment groups
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6-8 weeks
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Changes in other parameters including New York Heart Association (NYHA) class, HR, BP, LV volumes, stroke work-index, and QoL scores will also be analyzed. The subgroups of ischemic and non-ischemic etiology will be analyzed
Prazo: at 6-8 weeks
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at 6-8 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Rob S Beanlands, MD, FRCP C, Ottawa Heart Institute Research Corporation
Publicações e links úteis
Publicações Gerais
- Yoshinaga K, Burwash IG, Leech JA, Haddad H, Johnson CB, deKemp RA, Garrard L, Chen L, Williams K, DaSilva JN, Beanlands RS. The effects of continuous positive airway pressure on myocardial energetics in patients with heart failure and obstructive sleep apnea. J Am Coll Cardiol. 2007 Jan 30;49(4):450-8. doi: 10.1016/j.jacc.2006.08.059.
- Hall AB, Ziadi MC, Leech JA, Chen SY, Burwash IG, Renaud J, deKemp RA, Haddad H, Mielniczuk LM, Yoshinaga K, Guo A, Chen L, Walter O, Garrard L, DaSilva JN, Floras JS, Beanlands RS. Effects of short-term continuous positive airway pressure on myocardial sympathetic nerve function and energetics in patients with heart failure and obstructive sleep apnea: a randomized study. Circulation. 2014 Sep 9;130(11):892-901. doi: 10.1161/CIRCULATIONAHA.113.005893. Epub 2014 Jul 3.
- Johnson CB, Beanlands RS, Yoshinaga K, Haddad H, Leech J, de Kemp R, Burwash IG. Acute and chronic effects of continuous positive airway pressure therapy on left ventricular systolic and diastolic function in patients with obstructive sleep apnea and congestive heart failure. Can J Cardiol. 2008 Sep;24(9):697-704. doi: 10.1016/s0828-282x(08)70668-8.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças cardíacas
- Doenças cardiovasculares
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Distúrbios Respiratórios
- Distúrbios do Sono Intrínsecos
- Dissônias
- Distúrbios do Sono Vigília
- Sinais e Sintomas Respiratórios
- Insuficiência cardíaca
- Síndromes da Apneia do Sono
- Apnéia do Sono, Obstrutiva
- Apnéia
Outros números de identificação do estudo
- 2005982-01H
- HSFO #NA5665
- HSFO #T6426
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