None listed
Conditions
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 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.
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
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.
Sponsors
University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
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.
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 >15 minutes apart.
Outcome results
None listed