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Effect of Phlebotomy on Heartrate in Polycythemia Patients

Study Purpose

Single-centre, observational within-subject design: patients that undergo phlebotomies regularly for polycythemia will be measured continuously by wearables one week before until one week after a phlebotomy, for three phlebotomies.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05396170
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Leiden University Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Jaap Jan Zwaginga, MD, PhD
Principal Investigator Affiliation LUMC
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Polycythemia
Additional Details

Rationale: Little is known about the effect of a hemoglobin-shift on patients, anaemic, non-anaemic or even polycythaemic. It has been established that severe anaemia has deteriorating effects on the patient, which can be (partially) reversed by treatments like transfusion, erythropoietin stimulating agents or iron/vitamin supplements, depending of the etiology of the anaemia. However, the optimal haemoglobin target and threshold for such treatments has yet to be determined. It is therefore necessary to evaluate what the exact effect of various haemoglobin levels, and a shift therein, is on the physiology of patients. Only then can the benefits be weighed properly against the risks for individual patients when considering treatment for anaemia, safety of blood donation, or expected effect of phlebotomy for polycythaemia. Primary Objective:

  • - Compare the per individual and per group effects of a reduction in Hb mass on physical functional outcomes (heart rate; activity parameters; QoL) in patients with polycythaemia.
Secondary Objectives:
  • - Compare the primary outcomes to data from the REMOTE-2 and FAINT-study (similar measurements in transfusion dependent patients and whole blood donors) Study design: Within-subject design.
Patients will be remotely monitored one week before phlebotomy until one week after. Study population: Adult patients with a polycythaemia requiring phlebotomies on a regular basis. Main study parameters: heart rate, blood pressure, activity parameters and quality of life.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

LUMC, Leiden, Zuid-Holland, Netherlands

Status

Recruiting

Address

LUMC

Leiden, Zuid-Holland,

Site Contact

Rik Tonino, MD

[email protected]

+31623248432

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