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

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ClinicalTrials.gov Identifier: NCT01044407
Recruitment Status : Unknown
Verified January 2010 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : January 7, 2010
Last Update Posted : January 25, 2010
Information provided by:
Imperial College London

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

Condition or disease Intervention/treatment Phase
Periodic Breathing Device: Pacemaker manipulation Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
Study Start Date : January 2010
Estimated Primary Completion Date : February 2010
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. stability of ventilation [ Time Frame: Per second ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044407

Contact: Darrel P Francis, MD +44 2075941264 d.francis@cheerful.com

United Kingdom
Imperial NHS Trust Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Darrel P Francis, MD         
Sponsors and Collaborators
Imperial College London
Principal Investigator: Darrel P Francis, MD Imperial College London

Responsible Party: Darrel Francis, Imperial College
ClinicalTrials.gov Identifier: NCT01044407     History of Changes
Other Study ID Numbers: P10678
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: January 25, 2010
Last Verified: January 2010

Keywords provided by Imperial College London:
sleep apnea

Additional relevant MeSH terms:
Heart Failure
Respiratory Aspiration
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes