Lipid Balance in Adult Sickle Cell Patients

Sickle Cell Disease Clinical Trial

— HDL2  

Official title:

Study of Lipid Balance in Adult Sickle Cell SS or SC Patients at Steady State and According to Clinical Phenotypes and During Acute Complications Acronym : "HDL2"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05780775
• Other study ID #: PAP_RIPH2_2021/09
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: November 30, 2028

Study information

• Verified date: December 2022
• Source: Centre Hospitalier Universitaire de Pointe-a-Pitre
• Contact: Valérie HAMONY-SOTER
• Phone: +590 590934686
• Email: valerie.soter[@]chu-guadeloupe.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to describe and/or searches for, in cohorts of adult sickle cell anemia (SCA) and SC sickle cell patients living in the French West Indies and followed by SCD Reference and Competence Centers: 1-lipids profiles and associations at steady state with occurrence of sickle cell disease (SCD) complications, 2-lipids profile evolution during and after prospective acute complications (vasoocclusive crises (VOC) and priapism), 3-lipids profile variation (inter /intra individuals) during 4 prospective years, 4- Genetic primary modulators of SCD complications, 5- insulin resistance (HOMA), free fatty acids and glycerol dosages, 6- lipids enzymes, lipidome and functionality of HDL in sub-groups of SCD population.

Description:

• Cohorts of sickle cell disease patients including sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.

• Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoprotein A-I and B.

Medical histories and prospective collection of SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity ≥2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy.

• Objective 4: to describe genetic primary modulators of SCD complications: fetal hemoglobin, alpha-thalassemia, haplotypes of beta S gene.

• Objective 5 will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism).

• Objective 6 will be performed in a sub-group of 90 individuals (n=15 with VOC and n= 15 without VOC, n=15 with priapism and n=15 without priapism, n= 15 with pulmonary arterial hypertension syndrome (PAH Sd) and n=15 without PAH Sd), as well as in a subgroup of n = 15 patients prospectively experiencing VOC and n = 15 patients prospectively experiencing priapism.

A collection of plasma is performed to fulfill objective 6, as well as a collection of blood cells for later researches.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: November 30, 2028
• Est. primary completion date: November 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged from 18 years and over

• Be affected with Sickle cell anemia or SC sickle cell

• Living in French Caribbean Islands of Guadeloupe or Martinique and followed by physicians issued from a French West Indies Sickle Cell Reference or Competence Center

• At steady state in the last month (without acute complication)

• To have given a written consent after information on the study.

Exclusion Criteria:

• Other hemoglobinopathies than sickle cell disease

• Pregnancy or lactation

• Patient under judicial protection or without freedom

• Patient not affiliated with a social security system

• Patient hospitalized for transfusion or bleeding in the last 3 months

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Complication
• Dyslipidemia
• Dyslipidemias
• Sickle Cell Disease

Intervention

Other:
• HDL2
to perform additional blood samples during acute phase of complications (realized between Day 1 and Day 3) in SCD patients hospitalized for vasoocclusive crisis or priapism.

Locations

Country	Name	City	State
France	Centre de Référence de la Drépanocytose	Le Lamentin	Martinique
France	Unité Transversale de la Drépanocytose	Pointe-à-Pitre	Guadeloupe

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Pointe-a-Pitre	Direction Générale de l'Offre de Soins

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	/ Lipids profiles at steady state, in sickle cell anemia and SC sickle cell adult patients, classified according to occurrence of complications.	Cohorts of sickle cell disease patients include sickle cell anemia (SCA) and SC sickle cell patients living in Guadeloupe and Martinique and followed by the Sickle cell disease (SCD) Reference and Competence Centers of French West Indies.; Lipid profile includes total cholesterol, HDL-cholesterol, non-HDL-cholesterol, LDL-cholesterol and triglycerides, apolipoproteins A-I and B.; Collection of medical histories and of prospective SCD complications include retinopathy, deafness, tinnitus, osteonecrosis, leg ulcers, strokes, acute chest syndrome, VOC, priapism, pulmonary arterial hypertension (PAH) and PAH sd (echocardiography diagnosed when tricuspid regurgitant jet velocity =2.5 m/sec), kidney disease: chronic renal insufficiency and/or nephropathy	6 years
Secondary	Kinetic study of lipids profile during hospitalized vasoocclusive crisis (VOC, with or without ACS) and Priapism, at return to steady state at first annual check-up, and one year after this last measurement	Past and prospective collection of previously listed SCD complications	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	total cholesterol	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	HDL-cholesterol	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	non HDL-cholesterol	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	LDL-cholesterol	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	triglycerides	6 years
Secondary	Study of variation of lipid profile, at steady state, during a 4 years period study intra and inter individual levels.	Apolipoproteins A-I and B	6 years
Secondary	Description of genetic primary modulators of SCD complications.	Fetal hemoglobin,	6 years
Secondary	Description of genetic primary modulators of SCD complications.	alpha-thalassemia,	6 years
Secondary	Description of genetic primary modulators of SCD complications.	haplotypes of beta S gene	6 years
Secondary	Dosages of Insulin resistance (HOMA),	Plasmatic insulinemia and glycemia (HOMA) will be performed in the entire cohort at inclusion and during prospective complications (VOC, priapism); lipids dosages	6 years
Secondary	free fatty acids	kinetic study of free fatty acids at inclusion and during prospective complications (VOC, priapism);	6 years
Secondary	plasmatic glycerol.	Kinetic study of plasmatic at inclusion and during prospective complications (VOC, priapism);	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of CETP (Cholesteryl Ester Transfer Protein) enzymes activities	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of L-CAT (Lécithine Cholestérol Acyl Transférase) enzymes activities	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of HDL lipidome,	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of HDL functionality,	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of free fatty acid	6 years
Secondary	Dosages of lipids enzymes, lipidome and functionality of HDL at steady state	The dosages of glycerol	6 years