Optimising Pacing for Contractility 2

NCT04201015 | Recruiting Phase 2

• 1 other identifier: 277578
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure, Systolic; Pacemaker

Outcome Measures

Primary Outcomes (1)

• Treadmill walk time

  Time walked during a standard incremental treadmill test

  6 months

Secondary Outcomes (7)

• Quality of life 1

  6 months

• Quality of life 2

  6 months

• Clinical composite score

  6 months

• Cardiac function during exercise measured by LVEF on echocardiogrpahy

  6 months

• Wall stress by cardiac MRI

  6 months

Study Arms (3)

Standard rate-response settings

NO INTERVENTION

Patients allocated to standard rate-response settings.

Rate-response settings off

ACTIVE COMPARATOR

Patients allocated to deactivated rate-response settings.

Device: Heart rate optimisation using force frequency data

Optimized rate-response settings

EXPERIMENTAL

Patients allocated to optimised rate-response settings.

Device: Heart rate optimisation using force frequency data

Interventions

Heart rate optimisation using force frequency data DEVICE

Programming heart rate rise according to the force frequency relationship

Optimized rate-response settings; Rate-response settings off

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical, echocardiographic and neurohormonal evidence of heart failure
• Cardiac pacemaker,
• Able to perform a peak exercise test,
• Willing and able to give informed consent.

You may not qualify if:

• Angina pectoris symptoms limiting exercise tolerance,
• Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality,
• Calcium channel blockers (CCBs).

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Leeds General Infirmary

Leeds, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Officials

• John Gierula, PhD

  University of Leeds

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaus K Witte, MD

CONTACT

01133926642; k.k.witte@leeds.ac.uk

Klaus Witte

CONTACT

01133926642; k.k.witte@leeds.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the technician doing the programming will know how the pacemaker has been set.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 16, 2019
• Study Start: June 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: after initial analysis and within three months of an apporoved request being made.
• Access Criteria: A request is made that the applicant's organisation deem ethically justified, and for which ethical approval is in place, and an analysis plan is available.

Locations

GB (1)