Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure
1 other identifier
interventional
110
1 country
1
Brief Summary
The investigators are examining the relationship between heart rate and heart contraction in patients with heart failure and pacemakers, aiming to improve quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
September 30, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedMay 11, 2016
May 1, 2016
1.8 years
July 22, 2015
May 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Exercise Time
Exercise duration in seconds
Assessed following the second treadmill test, 1 week later
Secondary Outcomes (1)
Change in Peak Oxygen Consumption (pVO2)
Assessed following the second treadmill test, 1 week later
Study Arms (2)
Standard pacemaker settings
NO INTERVENTIONStandard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange
Tailored pacemaker settings
EXPERIMENTALThe 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.
Interventions
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed
Eligibility Criteria
You may qualify if:
- stable CHF
- Cardiac Resynchronisation Therapy (CRT) device for \>3 months,
- able to walk on treadmill
You may not qualify if:
- unable to walk on treadmill,
- unstable angina pectoris
- uncontrolled heart rate
- prescribed calcium channel blocker
- significant aortic stenosis
- significant airways disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leeds Institute of Cardiovascular and Metabolic Medicine
Leeds, West Yorkshire, LS2 9JT, United Kingdom
Related Publications (9)
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.
PMID: 21185094BACKGROUNDShelton 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.
PMID: 20525704BACKGROUNDWitte 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.
PMID: 18571253BACKGROUNDThackray 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.
PMID: 16996845BACKGROUNDWitte 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.
PMID: 16923470BACKGROUNDWitte 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.
PMID: 16875998BACKGROUNDWitte 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.
PMID: 16159968BACKGROUNDThackray 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.
PMID: 12804929BACKGROUNDGierula 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.
PMID: 29226818DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
John Gierula, BSc
University of Leeds
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- NIHR Fellow and Cardiac Physiologist
Study Record Dates
First Submitted
July 22, 2015
First Posted
September 30, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2018
Last Updated
May 11, 2016
Record last verified: 2016-05