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OpenTrials
Completed

NCT Number: NCT06743139

Exploration of the Parameters Influencing the Effort Limitation of Patients Suffering From Homozygous Sickle Cell Anemia

The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients..

Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.

It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, Paris, 94010, France

About this study

The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients.

Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.

It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patient ≥ 18 years old
  • Affiliated with a social security scheme (beneficiary or beneficiary's beneficiary)

Exclusion criteria

  • Pregnant or breast-feeding women
  • Patients under guardianship, curatorship or legal protection
  • Patient under AME
  • Patient with a contraindication or unsuitability for physical activity on a cycloergometer

Treatment and study plan

Echography

Diagnostic Test

Simultaneous performance of an echocardiogram (part of the follow-up assessment for sickle cell heart disease) at rest and then during the cardiorespiratory stress test, and an ear capillary lactatemia analysis (already routinely performed to ensure the safety of the cardiorespiratory stress test) during the cardiorespiratory stress test routinely performed at Mondor University Hospital prior to cardiovascular rehabilitation programs.

Primary outcomes

  1. To define different clinico-biological profiles in patients with sickle cell disease (HbSS)

    Time frame: 4 weeks

    To define different clinico-biological profiles in patients with sickle cell disease (HbSS) by means of an exhaustive physiological analysis coupled with exercise.

Secondary outcomes

  1. Study resting characteristics to identify at an early stage patients with potential cardiac alterations.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Evaluation of Effort Limitation Parameters of Patients With Homozygous Sickle Cell Disease

Acronym: PHYSIO-EXDRE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2024
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.