Potential Biological and Physiological Determinants for Exercice in Patients With Polycythemia Vera
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospices Civils de Lyon
About this trial
Polycythemia vera (PV) is a rare haematological disorder characterized by an excessive production of red blood cells, associated with the somatic JAK2 V617F mutation. Clinical manifestations are varied and often include exercise intolerance but the underlying mechanisms remain poorly understood.
Physical activity is recommended in the management of chronic diseases, but it must be tailored to the physiological profile of the patient. A cardiopulmonary exercise test (CPET) is essential to ensure safety, detect possible contraindications, and assess maximal oxygen uptake (VO₂max), a key indicator of aerobic performance.
This prospective, experimental, non-randomized study will include patients with PV followed at Lyon Sud University Hospital and for which a CPET is scheduled in their routine clinical follow-up. The primary objective is to compare VO₂max between two groups of patients: moderate (\<10%) versus marked (≥10%) extent of blood viscosity increase after the completion of the CPET. The main hypothesis is that a significant increase in blood viscosity during exercise (≥10%) is a major limiting factor in oxygen transport and leads to a reduced VO₂max, reflecting impaired exercise tolerance.
Secondary analyses will focus on hemorheological parameters, tissue oxygenation, and cardiorespiratory and metabolic responses. The study aims to better understand the biological and physiological determinants of exercise intolerance in this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged at least 18 years and under 70.
Patient followed for a diagnosis of Polycytemia vera (confirmed JAK2 V617F mutation) and who were prescribed a CPET because of their wish to resume regular physical activity.
Patient affiliated with or benefiting from a social security scheme.
Disqualifiers
Any known history of heart disease or chronic respiratory illness likely to affect VO₂max independently of Polycytemia vera (e.g., asthma), according to the investigator's judgment.
Any known history of major thromboembolic complication, according to the investigator's judgment.
Body mass index (BMI) greater than 35, according to the investigator's judgment.
Participation in another interventional research protocol that may interfere with the present study, according to the investigator's judgment.
Trial design
Design model
Single group
Treatments tested in this trial
Research samples blood viscosity and viscoelasticity:
Biological/VaccineResearch samples: Blood rheology: hematocrit, blood viscosity, deformability and erythrocyte aggregation, viscoelasticity
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: Polycythemia veraExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood viscosity (Centipoise) at 6 shear rates.
Blood viscosity will be measured using a cone-plate viscometer (Brookfield, model LVDVII+ PRO, cone CPE 40) on native hematocrit blood, at 7 different shear rates: 2.25, 4.5, 11.5, 22.5, 45, 90, and 225 s-¹, using an ascending ramp shear protocol.
Time frame
Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPETSecondary outcomes
1
Rheological properties of blood: deformability and aggregation of erythrocytes
Analyses will be performed on EDTA tubes. Erythrocyte deformability will be measured by ektacytometry at 9 shear stresses (0.3-30 Pa) under isotonic conditions. Maximal elongation index (EImax) and shear stress for 50% deformation (SS₁/₂) will be recorded. Aggregation/disaggregation will be assessed by syllectometry at 40% hematocrit. Parameters include aggregation index (AI) and minimal shear rate (γmin) for full disaggregation
Time frame
Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET.2
Viscoelasticity of blood
Viscoelastic properties of blood will be assessed using rotational thromboelastometry (ROTEM delta) on citrated blood tubes. The following tests will be performed: NATEM, TEMACT, FIBTEM, and EXTEM. For each test, the following parameters will be measured: clotting time (CT, in seconds), clot amplitude at 5, 10, 20, and 30 minutes (A5, A10, A20, A30, in mm), alpha angle (indicating clot formation velocity, in degrees), maximum clot firmness (in mm), percentage of clot lysis at 30 minutes (LI30), as well as lysis onset time (LOT) and total lysis time (LT), both expressed in seconds
Time frame
Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET3
Tissue and haemoglobin oxygenation with near-infrared spectroscopy (NIRS)
Near-infrared spectroscopy (NIRS) will be performed using the Portamon MKIII system (Artinis) with a sampling rate of 100 Hz. This non-invasive technique involves placing surface electrodes on the skin over the vastus lateralis muscle, halfway between the anterior superior iliac spine and the patella. NIRS enables continuous monitoring of changes in oxyhemoglobin (HbO₂) and deoxyhemoglobin (HHb) concentrations, allowing for the calculation of the tissue oxygenation index (TOI)
Time frame
Measurement will be performed during the CPET.Sponsors and contacts
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Source ClinicalTrials.gov
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