NCT04201015 Optimising Pacing for Contractility 2
| NCT ID | NCT04201015 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Leeds |
| Condition | Heart Failure, Systolic |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 400 participants in total. It began in 2020-06-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Clinical, echocardiographic and neurohormonal evidence of heart failure * Cardiac pacemaker, * Able to perform a peak exercise test, * Willing and able to give informed consent. Exclusion Criteria: * Angina pectoris symptoms limiting exercise tolerance, * Unstable heart failure symptoms (medical therapy changes in last three months), Poor image quality, * Calcium channel blockers (CCBs).
Contact & Investigator
John Gierula, PhD
PRINCIPAL INVESTIGATOR
University of Leeds
Frequently Asked Questions
Who can join the NCT04201015 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure, Systolic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04201015 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04201015 currently recruiting?
Yes, NCT04201015 is actively recruiting participants. Contact the research team at k.k.witte@leeds.ac.uk for enrollment information.
Where is the NCT04201015 trial being conducted?
This trial is being conducted at Leeds, United Kingdom.
Who is sponsoring the NCT04201015 clinical trial?
NCT04201015 is sponsored by University of Leeds. The principal investigator is John Gierula, PhD at University of Leeds. The trial plans to enroll 400 participants.
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