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
University of Adelaide
160 participants
Mar 6, 2024
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
Plain Language Summary
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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-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)
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ACTRN12623001187639