Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure
NCT ID: NCT02563873
Last Updated: 2016-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
110 participants
INTERVENTIONAL
2015-10-31
2018-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Standard pacemaker settings
Standard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange
No interventions assigned to this group
Tailored pacemaker settings
The pacemaker settings will be altered to match optimal heart rate range with respect to cardiac contractility, as determined by echocardiography. This will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange.
Tailored pacemaker settings
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed
Interventions
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Tailored pacemaker settings
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed
Eligibility Criteria
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Inclusion Criteria
* Cardiac Resynchronisation Therapy (CRT) device for \>3 months,
* able to walk on treadmill
Exclusion Criteria
* unstable angina pectoris
* uncontrolled heart rate
* prescribed calcium channel blocker
* significant aortic stenosis
* significant airways disease
18 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
University of Leeds
OTHER
Responsible Party
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John Gierula
NIHR Fellow and Cardiac Physiologist
Principal Investigators
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John Gierula, BSc
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
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Leeds Institute of Cardiovascular and Metabolic Medicine
Leeds, West Yorkshire, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Al-Najjar Y, Witte KK, Clark AL. Chronotropic incompetence and survival in chronic heart failure. Int J Cardiol. 2012 May 17;157(1):48-52. doi: 10.1016/j.ijcard.2010.11.018. Epub 2010 Dec 23.
Shelton RJ, Ingle L, Rigby AS, Witte KK, Cleland JG, Clark AL. Cardiac output does not limit submaximal exercise capacity in patients with chronic heart failure. Eur J Heart Fail. 2010 Sep;12(9):983-9. doi: 10.1093/eurjhf/hfq086. Epub 2010 Jun 4.
Witte KK, Clark AL. Chronotropic incompetence does not contribute to submaximal exercise limitation in patients with chronic heart failure. Int J Cardiol. 2009 May 29;134(3):342-4. doi: 10.1016/j.ijcard.2008.02.014. Epub 2008 Jun 20.
Thackray SD, Ghosh JM, Wright GA, Witte KK, Nikitin NP, Kaye GC, Clark AL, Tweddel A, Cleland JG. The effect of altering heart rate on ventricular function in patients with heart failure treated with beta-blockers. Am Heart J. 2006 Oct;152(4):713.e9-13. doi: 10.1016/j.ahj.2006.07.007.
Witte KK, Clark AL. Resting left ventricular function, however measured, is poorly related to exercise capacity in chronic heart failure. Am J Cardiol. 2006 Sep 1;98(5):709-10. doi: 10.1016/j.amjcard.2006.05.002. Epub 2006 Jul 5. No abstract available.
Witte KK, Clark AL. Chronotropic incompetence in heart failure. J Am Coll Cardiol. 2006 Aug 1;48(3):595; author reply 595-6. doi: 10.1016/j.jacc.2006.05.014. Epub 2006 Jul 12. No abstract available.
Witte KK, Cleland JG, Clark AL. Chronic heart failure, chronotropic incompetence, and the effects of beta blockade. Heart. 2006 Apr;92(4):481-6. doi: 10.1136/hrt.2004.058073. Epub 2005 Sep 13.
Thackray SD, Witte KK, Nikitin NP, Clark AL, Kaye GC, Cleland JG. The prevalence of heart failure and asymptomatic left ventricular systolic dysfunction in a typical regional pacemaker population. Eur Heart J. 2003 Jun;24(12):1143-52. doi: 10.1016/s0195-668x(03)00199-4.
Gierula J, Paton MF, Lowry JE, Jamil HA, Byrom R, Drozd M, Garnham JO, Cubbon RM, Cairns DA, Kearney MT, Witte KK. Rate-Response Programming Tailored to the Force-Frequency Relationship Improves Exercise Tolerance in Chronic Heart Failure. JACC Heart Fail. 2018 Feb;6(2):105-113. doi: 10.1016/j.jchf.2017.09.018. Epub 2017 Dec 6.
Other Identifiers
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12/YH/0097
Identifier Type: -
Identifier Source: org_study_id
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