Impact of Phlebotomy on Heart Rate in Patients with Polycythemia
Phlebotomy in Blood Donors and Polycythemia Vera Patients- The Effect on Physiology: An Orienting Case-Cross Over Study
This study is testing how having blood drawn regularly affects heart rate and overall well-being in people with polycythemia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 1 site (Leiden, South Holland) |
| Trial ID | NCT05396170 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effects of phlebotomy on heart rate and other physical functional outcomes in patients with polycythemia. Participants will be monitored continuously using wearable devices for one week before and one week after three scheduled phlebotomies. The study seeks to understand how changes in hemoglobin levels affect patients' physiology, particularly focusing on heart rate, activity levels, and quality of life. By comparing individual and group outcomes, the research will provide insights into the optimal management of polycythemia and related treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with polycythemia who require regular phlebotomies.
Not a fit: Patients with significant cardiological disorders, poor functional status, or secondary polyglobulia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize treatment strategies for patients with polycythemia, improving their overall health and quality of life.
How similar studies have performed: While similar studies have been conducted, this specific approach focusing on the effects of phlebotomy on heart rate in polycythemia patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months) * Subjects aged ≥18 years * In possession of a smartphone * Life expectancy ≥ 3 months Exclusion Criteria: * Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG ≥3) * Participants with known arrhythmias or other significant cardiological conductivity disorders (Paroxysmal atrial fibrillation is allowed) * Hospitalized subjects * Subjects with a pacemaker. * Subjects with a secondary polyglobulia due to eg smoking or other pulmonary issues. * Scheduled oncological treatments or surgery during the study period.
Where this trial is running
Leiden, South Holland
- Lumc — Leiden, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Jaap Jan Zwaginga, MD, PhD — Lumc
- Study coordinator: Rik Tonino, MD
- Email: r.p.b.tonino@lumc.nl
- Phone: +31623248432
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.