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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
-
-
Ontario
-
Ottawa、Ontario、カナダ、K1Y 4W7
- University of Ottawa Heart Institute
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ: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.
他の名前:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
他の名前:
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
|
|
アクティブコンパレータ: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.
他の名前:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
他の名前:
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
|
|
他の: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.
他の名前:
PET imaging at Baseline, 1 week and 6-8 weeks.
CPAP begins after 6-8 week PET scan.
他の名前:
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measurements of oxidative metabolism (11C clearance rate constant 'k') and WMI
時間枠: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
時間枠:6-8 weeks
|
C-11 HED retention will be a measure myocardial SN pre-synaptic function in treatment groups
|
6-8 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
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
時間枠:at 6-8 weeks
|
at 6-8 weeks
|
協力者と研究者
捜査官
- 主任研究者:Rob S Beanlands, MD, FRCP C、Ottawa Heart Institute Research Corporation
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。