RecruitingACTRN12623001187639

Effect of Accelerated Pacing Rates on Exercise Tolerance, Quality of Life and Arrhythmia Burden in Patients with Evidence of Heart Failure with Preserved Ejection Fraction

Effect of Accelerated Pacing Rates on Exercise Tolerance, Quality of Life and Arrhythmia Burden in Patients with Evidence of Heart Failure with Preserved Ejection Fraction: The PACE-UP Randomised Controlled Trial


Sponsor

University of Adelaide

Enrollment

160 participants

Start Date

Mar 6, 2024

Study Type

Interventional

Conditions

Summary

Heart failure with preserved ejection fraction (HFpEF) is the most prevalent phenotype of heart failure. However, the treatment options for these patients remain limited. Permanent pacemakers are commonly used in the management of bradycardia (low heart rate), with many pacemaker patients also presenting with early HFpEF. This study is a prospective, two-arm randomised controlled trial including 160 participants with pacemakers and early HFpEF from Adelaide, South Australia. Participants will be randomised to an accelerated pacing rate (75bpm) or usual care (60bpm), performing follow-up at 4-weeks and 52-weeks post randomisation. It is hypothesised that increasing the heart rate settings compared to standard permanent pacemaker settings, will improve exercise tolerance, defined using peak oxygen consumption, at 12-months post-randomisation.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 90 Yearss

Plain Language Summary

Simplified for easier understanding

Heart failure with preserved ejection fraction (HFpEF) is a common form of heart failure where the heart muscle is too stiff rather than too weak. People with this condition often struggle to exercise and feel short of breath with exertion. Many of these patients also have a pacemaker — a device implanted to help regulate heart rhythm — and researchers believe that simply adjusting the heart rate settings on the pacemaker may improve exercise tolerance. This trial will randomly assign participants to have their pacemaker set to a slightly higher resting rate (75 beats per minute) versus the standard setting (60 beats per minute). The key question is whether the higher rate improves how much oxygen the body can use during exercise, which is measured at 12 months. You may be eligible if you are aged 18 to 90, have a pacemaker, and have been diagnosed with early or clinical HFpEF. The study is based in Adelaide, South Australia. If successful, this could offer a simple, no-drug way to help patients feel better and do more.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Participants randomised to the intervention arm will have their permanent pacemaker device adjusted to a lower rate setting of 75bpm, and followed up with assessments at 4-weeks and 52-weeks post-rand

Participants randomised to the intervention arm will have their permanent pacemaker device adjusted to a lower rate setting of 75bpm, and followed up with assessments at 4-weeks and 52-weeks post-randomisation. Adjustment of the lower rate setting will be performed by a cardiac physiologist during the baseline pacemaker interrogation at the Cardiovascular Centre, Norwood. The baseline pacemaker interrogation involves the participant remaining seated, while the cardiac physiologist places a wand over the participants chest where the device is located. This allows the pacemaker settings and performance to visualised by the cardiac physiologist on a pacemaker compatible computer. The pacemaker interrogation will be 15-minutes in duration, and include the adjustment of the lower rate settings. The cardiac physiologist modifying pacemaker settings and the supervising cardiologist will not be involved in assessment of any study outcomes.


Locations(1)

SA, Australia

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ACTRN12623001187639


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