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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06743139
Acronym
PHYSIO-EXDRE
Enrollment
30
Registered
2024-12-19
Start date
2021-03-10
Completion date
2022-03-11
Last updated
2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analyze the Results of Cardiorespiratory Stress Tests, Capillary Lactatemia Measurements at the Ear, Resting and Stress Echocardiography

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.

Interventions

DIAGNOSTIC_TESTEchography

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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To define different clinico-biological profiles in patients with sickle cell disease (HbSS)4 weeksTo define different clinico-biological profiles in patients with sickle cell disease (HbSS) by means of an exhaustive physiological analysis coupled with exercise.

Secondary

MeasureTime frame
Study resting characteristics to identify at an early stage patients with potential cardiac alterations.4 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026