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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563873
Recruitment Status : Unknown
Verified May 2016 by John Gierula, University of Leeds.
Recruitment status was:  Recruiting
First Posted : September 30, 2015
Last Update Posted : May 11, 2016
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
John Gierula, University of Leeds

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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Device: Tailored pacemaker settings Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bowditch Revisited: Defining the Optimum Heart Rate Range in Chronic Heart Failure
Study Start Date : October 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: Standard pacemaker settings
Standard pacemaker settings will be programmed and the patient will complete a symptom limited exercise tolerance test with metabolic gas exchange
Experimental: 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.
Device: Tailored pacemaker settings
Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed




Primary Outcome Measures :
  1. Change in Exercise Time [ Time Frame: Assessed following the second treadmill test, 1 week later ]
    Exercise duration in seconds


Secondary Outcome Measures :
  1. Change in Peak Oxygen Consumption (pVO2) [ Time Frame: Assessed following the second treadmill test, 1 week later ]
    Peak Oxygen Consumption (pVO2) measured by metabolic gas exchange



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563873


Contacts
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Contact: John Gierula, BSc 00441333923131 J.Gierula@leeds.ac.uk
Contact: Klaus K Witte, MD k.k.witte@leeds.ac.uk

Locations
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United Kingdom
Leeds Institute of Cardiovascular and Metabolic Medicine Recruiting
Leeds, West Yorkshire, United Kingdom, LS2 9JT
Contact: John Gierula, BSc    01133923131    j.gierula@leeds.ac.uk   
Sponsors and Collaborators
University of Leeds
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: John Gierula, BSc University of Leeds
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Gierula, NIHR Fellow and Cardiac Physiologist, University of Leeds
ClinicalTrials.gov Identifier: NCT02563873    
Other Study ID Numbers: 12/YH/0097
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: May 11, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases