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

History of Changes

Purpose

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

Condition	Intervention	Phase
Periodic Breathing	Device: Pacemaker manipulation	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science
Official Title:	Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

stability of ventilation [ Time Frame: Per second ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	January 2010
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01044407

Contacts

Contact: Darrel P Francis, MD

+44 2075941264

d.francis@cheerful.com

Locations

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

Sponsors and Collaborators

Imperial College London

Investigators

Principal Investigator:

Darrel P Francis, MD

Imperial College London

More Information

Publications:

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.

Responsible Party:	Darrel Francis, Imperial College
ClinicalTrials.gov Identifier:	NCT01044407 History of Changes
Other Study ID Numbers:	P10678
Study First Received:	January 6, 2010
Last Updated:	January 22, 2010
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:

respiration
sleep apnea
pacemaker

Additional relevant MeSH terms:

Respiratory Aspiration
Heart Failure
Respiration Disorders
Respiratory Tract Diseases

Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013

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