Impact of Phlebotomy on Heart Rate in Patients with Polycythemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.