Characterization of Exercise Intolerance in Patients With Polycythemia Vera: Study of Potential Biological and Physiological Determinants.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Blood viscosity (Centipoise) at 6 shear rates.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged at least 18 years and under
- •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.
排除标准
- •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.
结局指标
主要结局
Blood viscosity (Centipoise) at 6 shear rates.
时间窗: Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET
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.
次要结局
- Rheological properties of blood: deformability and aggregation of erythrocytes(Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET.)
- Viscoelasticity of blood(Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET)
- Tissue and haemoglobin oxygenation with near-infrared spectroscopy (NIRS)(Measurement will be performed during the CPET.)