Optimizing heart rate for better heart function in patients with heart failure
Mechanisms, Safety and Efficacy of Optimising Pacemaker Heart Rate for Contractility: Effects on Walk Time, Cardiac Remodelling and Quality of Life
This study is testing if adjusting heart rate settings in pacemakers can help people with heart failure feel better and exercise more easily.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leeds Academic / other |
| Locations | 1 site (Leeds) |
| Trial ID | NCT04201015 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of optimizing heart rate programming in patients with chronic heart failure who have a pacemaker. It will compare the effects of optimized heart rate settings against standard and no rate-response programming over a six-month period. The study will involve 450 adult participants who will undergo echocardiographic assessments, exercise tests, and quality of life evaluations. The goal is to see if optimized programming leads to improved exercise capacity and quality of life without negatively impacting heart function or device longevity.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with chronic heart failure and a cardiac pacemaker who can perform a peak exercise test.
Not a fit: Patients with unstable heart failure symptoms or those on calcium channel blockers may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance exercise capacity and quality of life for patients with heart failure.
How similar studies have performed: Previous studies have shown promising short-term improvements with similar heart rate optimization approaches, but this trial aims to assess long-term benefits.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Leeds
- Leeds General Infirmary — Leeds, United Kingdom (Recruiting)
Study contacts
- Principal investigator: John Gierula, PhD — University of Leeds
- Study coordinator: Klaus K Witte, MD
- Email: k.k.witte@leeds.ac.uk
- Phone: 01133926642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.