Assessing how heart rate affects blood flow in patients with pacemakers
Assessment of Stroke Volume and Cardiac Output in Response to Varying Heart Rates and Body Position - a Pacemaker Based Study
This study tests how changing heart rates affect blood flow in patients with pacemakers to see if it helps manage fainting spells.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Calgary Academic / other |
| Locations | 1 site (Calgary, Alberta) |
| Trial ID | NCT03446326 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between heart rate, stroke volume, and cardiac output in patients with permanent pacemakers. By safely manipulating heart rates, the researchers aim to understand how varying heart rates influence these hemodynamic parameters. The study will utilize non-invasive assessments to gather data on cardiac function while considering the patient's position (supine vs. upright). The findings could provide insights into the effectiveness of pacemakers in managing vasovagal syncope.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with an implanted permanent pacemaker or defibrillator and a left ventricular ejection fraction greater than 50%.
Not a fit: Patients who are unable or unwilling to provide informed consent or those with a clinical need for a cardiac resynchronization device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the management of vasovagal syncope in patients with pacemakers.
How similar studies have performed: While there is limited data on this specific approach, the study builds on existing knowledge of cardiovascular hemodynamics and the use of pacemakers in treating syncope.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-70 years (inclusive) * Implanted permanent pacemaker or implanted defibrillator capable of atrial and ventricular pacing * LV ejection fraction \>50% Exclusion Criteria: * Unable or unwilling to provide informed consent * Clinical need for a cardiac resynchronization device
Where this trial is running
Calgary, Alberta
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Satish R Raj, MD MSCI — University of Calgary
- Study coordinator: Satish R Raj, MD MSCI
- Email: satish.raj@ucalgary.ca
- Phone: 4032106152
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.