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

NCT06743139 | Completed

• 1 other identifier: APHP201322
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with homozygous sickle cell disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris-Hôpital Henri Mondor

Créteil, Paris, 94010, France

Location

Related Publications (5)

• 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.

  PMID: 23877260 BACKGROUND

• http://beh.santepubliquefrance.fr/beh/2015/8/2015_8_2.html

  BACKGROUND

• 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.

  PMID: 20029950 BACKGROUND

• 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.

  PMID: 31005979 BACKGROUND

• 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.

  PMID: 28935040 BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Thomas D'HUMIERES, Dr

  Henri Mondor University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: December 19, 2024
• Study Start: March 10, 2021
• Primary Completion: March 10, 2022
• Study Completion: March 11, 2022
• Last Updated: December 19, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)