Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure

Chronic Heart Failure Clinical Trial

Official title:

Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02563873
• Other study ID #: 12/YH/0097
• Status: Recruiting
• Phase: N/A
• First received: July 22, 2015
• Last updated: May 10, 2016
• Start date: October 2015
• Est. completion date: July 2018

Study information

• Verified date: May 2016
• Source: University of Leeds
• Contact: John Gierula, BSc
• Phone: 00441333923131
• Email: J.Gierula[@]leeds.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Device:
• Tailored pacemaker settings
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed

Locations

Country	Name	City	State
United Kingdom	Leeds Institute of Cardiovascular and Metabolic Medicine	Leeds	West Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Witte KK, Clark AL. Chronotropic incompetence in heart failure. J Am Coll Cardiol. 2006 Aug 1;48(3):595; author reply 595-6. Epub 2006 Jul 12. — View 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. Epub 2006 Jul 5. — View 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. Epub 2005 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Exercise Time	Exercise duration in seconds	Assessed following the second treadmill test, 1 week later	No
Secondary	Change in Peak Oxygen Consumption (pVO2)	Peak Oxygen Consumption (pVO2) measured by metabolic gas exchange	Assessed following the second treadmill test, 1 week later	No