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

May 10, 2016 updated by: John Gierula, University of Leeds
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS2 9JT
        • Recruiting
        • Leeds Institute of Cardiovascular and Metabolic Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Exercise Time
Time Frame: Assessed following the second treadmill test, 1 week later
Exercise duration in seconds
Assessed following the second treadmill test, 1 week later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessed following the second treadmill test, 1 week later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leeds

Collaborators

National Institute for Health Research, United Kingdom

Investigators

  • Principal Investigator: John Gierula, BSc, University of Leeds

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

July 22, 2015

First Submitted That Met QC Criteria

September 28, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12/YH/0097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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