このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2018年5月28日 更新者: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.

調査の概要

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:

  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.

研究の種類

介入

入学 (実際)

67

段階

  • フェーズ 1

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Ontario
      • Ottawa、Ontario、カナダ、K1Y 4W7
        • University of Ottawa Heart Institute

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

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

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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:
  • ペット
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
他の名前:
  • ペット
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
  • ペット
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:
  • ペット
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
他の名前:
  • ペット
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
  • ペット
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:
  • ペット
PET imaging at Baseline, 1 week and 6-8 weeks. CPAP begins after 6-8 week PET scan.
他の名前:
  • ペット
PET scan at baseline and 6-8 weeks, no CPAP therapy
他の名前:
  • ペット

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

ここでは、この調査に関係する人々や組織を見つけることができます。

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

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2005年7月1日

一次修了 (実際)

2011年6月1日

研究の完了 (実際)

2011年12月1日

試験登録日

最初に提出

2008年9月18日

QC基準を満たした最初の提出物

2008年9月19日

最初の投稿 (見積もり)

2008年9月22日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月30日

QC基準を満たした最後の更新が送信されました

2018年5月28日

最終確認日

2018年5月1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。

購読する