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

Completed

• Conditions: Analyze the Results of Cardiorespiratory Stress Tests; Resting and Stress Echocardiography; Capillary Lactatemia Measurements at the Ear

• Registration Number: NCT06743139
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-03-10
• Primary Completion: 2022-03-10
• Study Completion: 2022-03-11
• Study First Submitted: 2022-06-27
• Status Verified: 2023-07
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To define different clinico-biological profiles in patients with sickle cell disease (HbSS)	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 Outcome Measures

Name	Time	Method
Study resting characteristics to identify at an early stage patients with potential cardiac alterations.	4 weeks

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor; 🇫🇷 Créteil, Paris, France