Clinical trial NCT06743139: Exploration of the Parameters Influencing the Effort Limitation of Patients Suffering From Homozygous Sickle Cell Anemia
Official title: Evaluation of Effort Limitation Parameters of Patients With Homozygous Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analyze the Results of Cardiorespiratory Stress Tests
Resting and Stress Echocardiography
Capillary Lactatemia Measurements at the Ear
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-12-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with homozygous sickle cell disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: To define different clinico-biological profiles in patients with sickle cell disease (HbSS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Study resting characteristics to identify at an early stage patients with potential cardiac alterations.
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor
state: Paris
Study officials:
affiliation: Henri Mondor University Hospital
name: Thomas D'HUMIERES, Dr
role: STUDY_DIRECTOR
References:
citation: Fletcher GF, Ades PA, Kligfield P, Arena R, Balady GJ, Bittner VA, Coke LA, Fleg JL, Forman DE, Gerber TC, Gulati M, Madan K, Rhodes J, Thompson PD, Williams MA; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Nutrition, Physical Activity and Metabolism, Council on Cardiovascular and Stroke Nursing, and Council on Epidemiology and Prevention. Exercise standards for testing and training: a scientific statement from the American Heart Association. Circulation. 2013 Aug 20;128(8):873-934. doi: 10.1161/CIR.0b013e31829b5b44. Epub 2013 Jul 22. No abstract available.
citation: http://beh.santepubliquefrance.fr/beh/2015/8/2015_8_2.html
citation: Fitzhugh CD, Lauder N, Jonassaint JC, Telen MJ, Zhao X, Wright EC, Gilliam FR, De Castro LM. Cardiopulmonary complications leading to premature deaths in adult patients with sickle cell disease. Am J Hematol. 2010 Jan;85(1):36-40. doi: 10.1002/ajh.21569.
citation: Hammoudi N, Lionnet F, Redheuil A, Montalescot G. Cardiovascular manifestations of sickle cell disease. Eur Heart J. 2020 Apr 1;41(13):1365-1373. doi: 10.1093/eurheartj/ehz217.
citation: Guazzi M, Bandera F, Ozemek C, Systrom D, Arena R. Cardiopulmonary Exercise Testing: What Is its Value? J Am Coll Cardiol. 2017 Sep 26;70(13):1618-1636. doi: 10.1016/j.jacc.2017.08.012.