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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Imperial College London.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Imperial College London
ClinicalTrials.gov Identifier:
NCT01044407
First received: January 6, 2010
Last updated: January 22, 2010
Last verified: January 2010

January 6, 2010
January 22, 2010
January 2010
February 2010   (final data collection date for primary outcome measure)
stability of ventilation [ Time Frame: Per second ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044407 on ClinicalTrials.gov Archive Site
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Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.

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

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Periodic Breathing
Device: Pacemaker manipulation
Alternation of cardiac output by modulation of heart rate, atrioventricular delay and modulation from biventricular pacing to right ventricular pacing (where applicable)via a cardiac pacemaker
Not Provided
Baruah R, Manisty CH, Giannoni A, Willson K, Mebrate Y, Baksi AJ, Unsworth B, Hadjiloizou N, Sutton R, Mayet J, Francis DP. Novel use of cardiac pacemakers in heart failure to dynamically manipulate the respiratory system through algorithmic changes in cardiac output. Circ Heart Fail. 2009 May;2(3):166-74. Epub 2009 Mar 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
14
October 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
Both
18 Years to 80 Years
No
Contact: Darrel P Francis, MD +44 2075941264 d.francis@cheerful.com
United Kingdom
 
NCT01044407
P10678
No
Darrel Francis, Imperial College
Imperial College London
Not Provided
Principal Investigator: Darrel P Francis, MD Imperial College London
Imperial College London
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP