- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
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Ontario
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Ottawa, Ontario, Canada, K1Y 4W7
- University of Ottawa Heart Institute
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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.
Altri nomi:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Altri nomi:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Altri nomi:
|
|
Comparatore attivo: 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.
Altri nomi:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Altri nomi:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Altri nomi:
|
|
Altro: 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.
Altri nomi:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
Altri nomi:
PET scan at baseline and 6-8 weeks, no CPAP therapy
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI
Lasso di tempo: 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
|
|
C-11 Hydroxyephedrine (HED) retention
Lasso di tempo: 6-8 weeks
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C-11 HED retention will be a measure myocardial SN pre-synaptic function in treatment groups
|
6-8 weeks
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
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
Lasso di tempo: at 6-8 weeks
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at 6-8 weeks
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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Rob S Beanlands, MD, FRCP C, Ottawa Heart Institute Research Corporation
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie cardiache
- Malattia cardiovascolare
- Malattie del sistema nervoso
- Malattie delle vie respiratorie
- Disturbi respiratori
- Disturbi del sonno, intrinseci
- Dissonnie
- Disturbi del sonno e della veglia
- Segni e sintomi, respiratori
- Arresto cardiaco
- Sindromi da apnee notturne
- Apnea notturna, ostruttiva
- Apnea
Altri numeri di identificazione dello studio
- 2005982-01H
- HSFO #NA5665
- HSFO #T6426
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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