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

28 mei 2018 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

67

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Andere namen:
  • HUISDIER
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Andere namen:
  • HUISDIER
PET scan at baseline and 6-8 weeks, no CPAP therapy
Andere namen:
  • HUISDIER
Actieve vergelijker: 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.
Andere namen:
  • HUISDIER
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Andere namen:
  • HUISDIER
PET scan at baseline and 6-8 weeks, no CPAP therapy
Andere namen:
  • HUISDIER
Ander: 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.
Andere namen:
  • HUISDIER
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
Andere namen:
  • HUISDIER
PET scan at baseline and 6-8 weeks, no CPAP therapy
Andere namen:
  • HUISDIER

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI
Tijdsspanne: 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
Tijdsspanne: 6-8 weeks
C-11 HED retention will be a measure myocardial SN pre-synaptic function in treatment groups
6-8 weeks

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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
Tijdsspanne: at 6-8 weeks
at 6-8 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2005

Primaire voltooiing (Werkelijk)

1 juni 2011

Studie voltooiing (Werkelijk)

1 december 2011

Studieregistratiedata

Eerst ingediend

18 september 2008

Eerst ingediend dat voldeed aan de QC-criteria

19 september 2008

Eerst geplaatst (Schatting)

22 september 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 mei 2018

Laatste update ingediend die voldeed aan QC-criteria

28 mei 2018

Laatst geverifieerd

1 mei 2018

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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