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
South Australian Health and Medical Research InstituteDataset description
This is a dataset of 160 participants (adults aged 35-75 years old) 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. The primary outcome is peak oxygen consumption (VO2peak) assessed by cardiopulmonary exercise testing on an upright cycle ergometer, recorded by a metabolic cart, at baseline and then at 52-weeks post-randomisation.Date Information
Source Study
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12623001187639
Funding
University, University of Adelaide
Scientific enquiries
Dr Adrian Elliott
Brief 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 .... Read more
Key Inclusion Criteria
• Adults 18-90 years old with a pacemaker. • Preclinical or clinical heart failure with preserved ejection fraction according to the diagnostic criteria of the HFA of the ESC. • Sinus node dysfunction with intact AV node conduction or minimal RV pacing (<20%) and paced QRS <150ms. OR • Impaired AV node conduction with His bundle or left bundle branch area pacing, or biventricular pacing. • Subject is expected to remain available for follow-up visits.
Key Exclusion Criteria
• Left ventricular ejection fraction <45%. • Inability to participate in exercise testing due to musculoskeletal disease or other active diseases. • Myocardial infarction within the past 12 months. • Infiltrative cardiomyopathy. • Hypertrophic cardiomyopathy. • More than moderate valvular stenosis or regurgitation. • Aortic valve replacement in the past one year. • Significant primary pulmonary disease on home oxygen. • Uncontrolled hypertension as defined by BP >160/100 mmHg on two measurements .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 160
Min. age 18 Years
Max. age 90 Years
Sex Both males and females
Condition category Heart failure with preserved ejection fraction , Sinus Node Disease
Condition code Cardiovascular
Intervention
Intervention code Treatment: Devices
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 .... Read more
Comparison
Control group Active
Participants randomised to the usual care arm will be maintained at the standard 60bpm setting. To facilitate participant blinding, participants in the usual care arm will still undergo a baseline pacemaker interrogation.
Outcomes
Outcome: Peak oxygen consumption (VO2peak).Timepoint: Baseline and 52-weeks post-randomisation.