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Набор скоро начнётся NCT07341048

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

Без фазы С лечением Polycythemia Polycythemia Vera (PV)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Research samples blood viscosity and viscoelasticity:.
Кому может быть актуально
Состояния в реестре: Polycythemia, Polycythemia Vera (PV). Базовые параметры: 18 лет — 70 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
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Официальное название

Characterization of Exercise Intolerance in Patients With Polycythemia Vera: Study of Potential Biological and Physiological Determinants.

Обзор

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.

Вмешательства

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

Первичные конечные точки

  • Blood viscosity (Centipoise) at 6 shear rates. [Срок оценки: Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET]
Вторичные конечные точки (3)
  • Rheological properties of blood: deformability and aggregation of erythrocytes [Срок оценки: Measurements will be performed at baseline (pre-test), at 3 minutes post-CPET, and at 60 minutes post-CPET.]
  • Viscoelasticity of blood [Срок оценки: 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) [Срок оценки: Measurement will be performed during the CPET.]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Department of Sports Medicine and Physical Activity. Pulmonary Function Testing. Croix Rou — Lyon

Идентификаторы

NCT: NCT07341048 · 69HCL25_0364 · 2025-A01032-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗