Optimising Pacing for Contractility 2

Study acronym: OPT-cont 2
StatusUnknown
PhasePhase 2/3
Started

Record status This record was last updated September 26, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Minor Study description revised
    • Eligibility criteria expanded, about 3 words
    v8
  3. Minor Re-verified, no change to tracked fieldsv7
  4. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024
    • Study completion date: Dec 31, 2023 to Mar 31, 2025
    v6
  5. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2023
    • Enrollment target: 360 to 400
    • Study description expanded, about 1 word
    v5
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  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 1, 2020 to Jun 1, 2020
    • Site details revised
    v3
  3. Notable Start date: Jan 1, 2020 to May 1, 2020v2
  1. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT04201015
Lead Sponsor University of Leeds
Conditions
(from sponsor)
Heart Failure, Systolic, Pacemaker
Related terms Heart Failure, Systolic
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov