Skip to content

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.

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01044407
Enrollment
14
Registered
2010-01-07
Start date
2010-01-31
Completion date
2010-10-31
Last updated
2010-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodic Breathing

Keywords

respiration, sleep apnea, pacemaker

Brief summary

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

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.

Interventions

DEVICEPacemaker 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

Sponsors

Imperial College London
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frame
stability of ventilationPer second

Countries

United Kingdom

Contacts

Primary ContactDarrel P Francis, MD
d.francis@cheerful.com+44 2075941264

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026