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Clinical Trials in France / NCT07341048
Starting soon Not applicable

Potential Biological and Physiological Determinants for Exercice in Patients With Polycythemia Vera

NCT07341048 · tracked via the Priya Life Science France tracker
Sponsor
Hospices Civils de Lyon
Phase
Not applicable
Started
2026-01
Last updated
2026-01-15

Condition(s) studied

PolycythemiaPolycythemia Vera (PV)

Investigational drug(s) / intervention(s)

Research samples blood viscosity and viscoelasticity:

Research samples blood viscosity and viscoelasticity:: Research samples: Blood rheology: hematocrit, blood viscosity, deformability and erythrocyte aggregation, viscoelasticity

Study summary

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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Adult subject under legal protection measures (guardianship, curatorship). * Subject currently receiving psychiatric care. * Subject deprived of liberty by judicial or administrative decision.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Sports Medicine and Physical Activity. Pulmonary Function Testing. Croix Rousse Hospital. Lyon France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07341048 on ClinicalTrials.gov ↗ ← All trials in France