Developing a New, Dynamic, Therapeutic Pacemaker Algorithm for Stabilising Periodic Breathing in Chronic Heart Failure.
1 other identifier
interventional
14
1 country
1
Brief Summary
To evaluate whether cardiac output manipulation via a cardiac pacemaker can stabilise ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedJanuary 25, 2010
January 1, 2010
1 month
January 6, 2010
January 22, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stability of ventilation
Per second
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial NHS Trust
London, London, W2 1NY, United Kingdom
Related Publications (1)
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.
PMID: 19808336BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Darrel P Francis, MD
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 6, 2010
First Posted
January 7, 2010
Study Start
January 1, 2010
Primary Completion
February 1, 2010
Study Completion
October 1, 2010
Last Updated
January 25, 2010
Record last verified: 2010-01