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

Primary Purpose

Periodic Breathing

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Pacemaker manipulation

About this trial

This is an interventional basic science trial for Periodic Breathing focused on measuring respiration, sleep apnea, pacemaker

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Imperial NHS TrustRecruiting

Outcomes

Primary Outcome Measures

stability of ventilation

Secondary Outcome Measures

Full Information

NCT ID

NCT01044407

First Posted

January 6, 2010

Last Updated

January 22, 2010

Sponsor

Imperial College London

1. Study Identification

Unique Protocol Identification Number

NCT01044407

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Unknown status

Study Start Date

January 2010 (undefined)

Primary Completion Date

February 2010 (Anticipated)

Study Completion Date

October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Imperial College London

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodic Breathing

Keywords

respiration, sleep apnea, pacemaker

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Pacemaker manipulation

Intervention Description

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 Measure Information:

Title

stability of ventilation

Time Frame

Per second

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Darrel P Francis, MD

Phone

+44 2075941264

d.francis@cheerful.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Darrel P Francis, MD

Organizational Affiliation

Imperial College London

Official's Role

Principal Investigator

Facility Information:

Facility Name

Imperial NHS Trust

City

London

ZIP/Postal Code

W2 1NY

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Darrel P Francis, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19808336

Citation

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. doi: 10.1161/CIRCHEARTFAILURE.108.806588. Epub 2009 Mar 23.

Results Reference

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

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