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CPAP Therapy in Patients With Heart Failure and Obstructive Sleep Apnea. (PET-OSA)

28 mai 2018 mis à jour par: Rob Beanlands, Ottawa Heart Institute Research Corporation

Effects of Continuous Positive Airway Pressure Therapy on Myocardial Energetics and Sympathetic Nerve Function in Patients With Heart Failure and Obstructive Sleep Apnea.

Heart failure affects approximately 5-6 million North Americans and is increasing in prevalence. Sleep-related disorders, such as obstructive sleep apnea (OSA) often coexist (11-37% incidence) with heart failure. OSA is the repeated temporary interruption of breathing during sleep and occurs when the air passages in the upper respiratory tract become blocked during sleep. OSA adversely affects the cardiovascular system resulting in hypoxia (decrease in oxygen supply), which decreases the oxygen supply to the heart. Patients with OSA are treated with continuous positive airway pressure (CPAP). It has also been shown that CPAP reduces angina during sleep, minimizes sympathetic nervous system (SNS) activation and improves left ventricular (LV) function, although the mechanism of action is not clear. Carbon-11 acetate PET imaging allows for the assessment of how the heart works and how efficiently the heart uses oxygen in certain circumstances. Carbon-11 hydroxyephedrine (HED) measures cardiac nervous system activity, which may have an effect on heart rate. The study will evaluate the term effects of continuous positive airway pressure (CPAP), a common treatment for patients with OSA, on the heart's efficiency or ability to work and its effect on the nervous system activity of the heart. Two patient groups will be evaluated 1.) patients with congestive heart failure and obstructive sleep apnea will be randomized to early or late CPAP to address the primary hypothesis of the study and 2.) patients with congestive heart failure only (matched control group). Both the primary randomized study group and secondary study group will be evaluated using [11C]acetate PET, [11C]HED PET and echocardiography. Measurements will be obtained at baseline, 1 week (where possible) and 6-8 weeks.

Aperçu de l'étude

Description détaillée

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:

  1. 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;
  2. 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,

  1. 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;
  2. 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)
  3. 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.

Type d'étude

Interventionnel

Inscription (Réel)

67

Phase

  • La phase 1

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

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute

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 et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

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

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 1
Heart Failure-OSA Group, randomized to early CPAP
PET imaging at baseline, 1 week and 6-8 weeks. CPAP begins after baseline PET scan.
Autres noms:
  • ANIMAUX
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Autres noms:
  • ANIMAUX
PET scan at baseline and 6-8 weeks, no CPAP therapy
Autres noms:
  • ANIMAUX
Comparateur actif: 2
Heart Failure-OSA Group, randomized to late CPAP
PET imaging at baseline, 1 week and 6-8 weeks. CPAP begins after baseline PET scan.
Autres noms:
  • ANIMAUX
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Autres noms:
  • ANIMAUX
PET scan at baseline and 6-8 weeks, no CPAP therapy
Autres noms:
  • ANIMAUX
Autre: 3
Heart Failure- no OSA, no CPAP therapy, observational group
PET imaging at baseline, 1 week and 6-8 weeks. CPAP begins after baseline PET scan.
Autres noms:
  • ANIMAUX
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Autres noms:
  • ANIMAUX
PET scan at baseline and 6-8 weeks, no CPAP therapy
Autres noms:
  • ANIMAUX

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI
Délai: at 6-8 weeks
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
at 6-8 weeks
C-11 Hydroxyephedrine (HED) retention
Délai: 6-8 weeks
C-11 HED retention will be a measure myocardial SN pre-synaptic function in treatment groups
6-8 weeks

Mesures de résultats secondaires

Mesure des résultats
Délai
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
Délai: at 6-8 weeks
at 6-8 weeks

Collaborateurs et enquêteurs

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

Les enquêteurs

  • Chercheur principal: Rob S Beanlands, MD, FRCP C, Ottawa Heart Institute Research Corporation

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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

1 juillet 2005

Achèvement primaire (Réel)

1 juin 2011

Achèvement de l'étude (Réel)

1 décembre 2011

Dates d'inscription aux études

Première soumission

18 septembre 2008

Première soumission répondant aux critères de contrôle qualité

19 septembre 2008

Première publication (Estimation)

22 septembre 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 mai 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

28 mai 2018

Dernière vérification

1 mai 2018

Plus d'information

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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