Mechanisms, Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life

Who is this study for? Patients with Heart Failure
What treatments are being studied? Heart Rate Optimisation Using Force Frequency Data
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

The investigators have demonstrated that they can reliably identify an optimum heart rate range for contractility of the left ventricle in patients with chronic heart failure (CHF). They have also demonstrated in an acute cross-over and a small parallel group feasibility study that keeping the heart rate in this range (versus standard rate-response programming) in patients with CHF is associated with increased exercise time on a treadmill (around 60s or 10%). They now want to explore in a randomised, placebo-controlled 3-arm parallel group trial whether optimal programming versus standard rate-response programming versus no rate-response programming for 6 months leads to appreciable improvements in exercise time and quality of life, while having no adverse effects on left ventricular function and battery longevity and what the mechanisms of this might be. 450 patients with CHF and a pacemaker will undergo the non-invasive echocardiographic assessment to establish the force frequency relationship and the optimal heart rate for contractility. They will then perform a treadmill walk test, complete quality of life questionnaires and be offered the opportunity to participate in a series of mechanistic substudies. They will then be randomised to optimal rate-response settings, standard rate response settings or no rate-response settings and followed up at 6 months at which point the tests will be repeated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Clinical, echocardiographic and neurohormonal evidence of heart failure

• Cardiac pacemaker,

• Able to perform a peak exercise test,

• Willing and able to give informed consent.

Locations
Other Locations
United Kingdom
Leeds General Infirmary
RECRUITING
Leeds
Contact Information
Primary
Klaus K Witte, MD
k.k.witte@leeds.ac.uk
01133926642
Backup
Klaus Witte
k.k.witte@leeds.ac.uk
01133926642
Time Frame
Start Date: 2020-06-01
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 400
Treatments
No_intervention: Standard rate-response settings
Patients allocated to standard rate-response settings.
Active_comparator: Rate-response settings off
Patients allocated to deactivated rate-response settings.
Experimental: Optimized rate-response settings
Patients allocated to optimised rate-response settings.
Related Therapeutic Areas
Sponsors
Leads: University of Leeds

This content was sourced from clinicaltrials.gov