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

Primary Purpose

Chronic Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Tailored pacemaker settings
Sponsored by
University of Leeds
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Leeds Institute of Cardiovascular and Metabolic MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard pacemaker settings

Tailored pacemaker settings

Arm Description

Standard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange

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.

Outcomes

Primary Outcome Measures

Change in Exercise Time
Exercise duration in seconds

Secondary Outcome Measures

Change in Peak Oxygen Consumption (pVO2)
Peak Oxygen Consumption (pVO2) measured by metabolic gas exchange

Full Information

First Posted
July 22, 2015
Last Updated
May 10, 2016
Sponsor
University of Leeds
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT02563873
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard pacemaker settings
Arm Type
No Intervention
Arm Description
Standard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange
Arm Title
Tailored pacemaker settings
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Tailored pacemaker settings
Intervention Description
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed
Primary Outcome Measure Information:
Title
Change in Exercise Time
Description
Exercise duration in seconds
Time Frame
Assessed following the second treadmill test, 1 week later
Secondary Outcome Measure Information:
Title
Change in Peak Oxygen Consumption (pVO2)
Description
Peak Oxygen Consumption (pVO2) measured by metabolic gas exchange
Time Frame
Assessed following the second treadmill test, 1 week later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Gierula, BSc
Phone
00441333923131
Email
J.Gierula@leeds.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Klaus K Witte, MD
Email
k.k.witte@leeds.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Gierula, BSc
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leeds Institute of Cardiovascular and Metabolic Medicine
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS2 9JT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Gierula, BSc
Phone
01133923131
Email
j.gierula@leeds.ac.uk

12. IPD Sharing Statement

Citations:
PubMed Identifier
21185094
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.
Results Reference
background
PubMed Identifier
20525704
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.
Results Reference
background
PubMed Identifier
18571253
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.
Results Reference
background
PubMed Identifier
16996845
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.
Results Reference
background
PubMed Identifier
16923470
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.
Results Reference
background
PubMed Identifier
16875998
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.
Results Reference
background
PubMed Identifier
16159968
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.
Results Reference
background
PubMed Identifier
12804929
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.
Results Reference
background
PubMed Identifier
29226818
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.
Results Reference
derived

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

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