跳至主要内容
临床试验/NCT01044407
NCT01044407
Unknown
2 期

Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.

Imperial College London1 个研究点 分布在 1 个国家目标入组 14 人2010年1月

概览

阶段
2 期
干预措施
未指定
疾病 / 适应症
Periodic Breathing
发起方
Imperial College London
入组人数
14
试验地点
1
主要终点
stability of ventilation
最后更新
16年前

概览

简要总结

To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.

详细描述

Many patients with heart failure exhibit a distinctive abnormal cyclical breathing pattern, 'periodic breathing'. This means that patients have a worse prognosis and they have debilitating symptoms including breathlessness, fatigue and disrupted sleep. Many of these patients also have cardiac pacemakers fitted, to improve their heart function. We have discovered a new physiological mechanism linking the heart and lungs, and have shown that by changing the programmed settings of a cardiac pacemakers, we can change a patient's breathing. If we increase the programmed pacing heart rate, we increase the rate of delivery of carbon dioxide to the lungs temporarily, which increases ventilation. When we reduce the programmed pacing heart rate, the converse happens. We aim to demonstrate this phenomenon scientifically, and to use this information to stabilise periodic breathing in heart failure patients using pacemakers. We then plan to continue to investigate whether we can show that sleep quality is improved in heart failure patients with periodic breathing, by our pacing protocol.

注册库
clinicaltrials.gov
开始日期
2010年1月
结束日期
2010年10月
最后更新
16年前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

入排标准

入选标准

  • Patients with cardiac pacemakers implanted on standard clinical grounds, and either normal left ventricular systolic function (as assessed by echocardiogram) or impaired left ventricular systolic function and stable breathing patterns (as assessed by screening in outpatients' clinic).

排除标准

  • Patients with atrial fibrillation with a ventricular rate of \>70 bpm will be excluded.
  • Patients with implantable cardiac defibrillators with anti-tachycardia therapy set at an unusually low rate (\<120 bpm), because it would limit the ability to vary the heart rate during the experiment.
  • Patients with significant respiratory disease (FEV1 \<50% predicted) will be excluded, as will patients with any condition that who have any condition precluding them from lying comfortably on a bed for 90 minutes.
  • Patients who have had a recent deterioration in condition i.e. admission in previous six weeks, those in a brittle condition and those who have end-stage renal failure requiring haemodialysis.

结局指标

主要结局

stability of ventilation

时间窗: Per second

研究点 (1)

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