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NCT07341048Not yet recruiting

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

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

Source: ClinicalTrials.gov · Last updated 15 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
54 (estimated)
First submitted
5 Jan 2026
Start date
Jan 2026
Primary completion date
May 2027
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT07341048

What you commit to

  • Study type: Interventional
  • Planned participants: 54
  • From Jan 2026 to the primary completion date, May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Subject currently receiving psychiatric care.

Other illness

  • 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.

Other

  • 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 deprived of liberty by judicial or administrative decision.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Department of Sports Medicine and Physical Activity. Pulmonary Function Testing. Croix Rousse Hospital.
Coordinator of this site? Confirm its status
LyonFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.