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Optimising Pacemaker Therapy for Contractility

NCT02964650 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2020-03-25

No results posted yet for this study

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 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 trial whether optimal programming versus standard 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.

60 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 and fill out a quality of life questionnaire. They will then be randomised to optimal rate-response settings or standard rate response settings and followed up at 6 months at which point the tests will be repeated.

Conditions

Interventions

DEVICE

Personalised rate-response settings

Rate response range fixed to limits suggested by force-frequency curve

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Klaus Witte, MD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-20
Primary Completion
2019-09-30
Completion
2019-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02964650 on ClinicalTrials.gov