Clinical trial NCT02563873: Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure
Official title: Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Heart Failure
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2015-09-30
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Heart rate lowering is a cornerstone of the management of chronic heart failure (CHF) and the degree of lowering is closely related to improvements in longevity, hospitalisation rate and heart function. The investigators have shown that increasing heart rates using pacemakers does not increase exercise capacity in CHF patients. This might be because the optimal heart rate range for contraction is narrower for patients with CHF. At higher heart rates, heart contraction might be less strong. The investigators now want to examine the relationship between heart rate and heart contraction in patients with heart failure and pacemakers. Tailored pacemaker heart rate setting's, individually optimised for heart contractility as assessed by cardiac ultrasound, will be investigated to examine the effects on exercise tolerance .

Eligibility criteria: Inclusion Criteria:

* stable CHF
* Cardiac Resynchronisation Therapy (CRT) device for \>3 months,
* able to walk on treadmill

Exclusion Criteria:

* unable to walk on treadmill,
* unstable angina pectoris
* uncontrolled heart rate
* prescribed calcium channel blocker
* significant aortic stenosis
* significant airways disease

Primary outcomes:
measure: Change in Exercise Time
timeFrame: Assessed following the second treadmill test, 1 week later
Secondary outcomes:
measure: Change in Peak Oxygen Consumption (pVO2)
timeFrame: Assessed following the second treadmill test, 1 week later
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Institute of Cardiovascular and Metabolic Medicine
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: John Gierula, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.